Viewing Study NCT01098006

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Ignite Creation Date: 2025-12-26 @ 4:01 PM
Ignite Modification Date: 2025-12-29 @ 12:27 AM
Study NCT ID: NCT01098006
Status: COMPLETED
Last Update Posted: 2020-02-25
First Post: 2010-04-01
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) related to study participation or to GSK concomitant products were collected during the study: from the time each subject consented to participate in the study up to study conclusion (i.e. during an approximate period of 22 months).', 'description': 'Other (non-serious) Adverse Events were not collected in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.025', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '5.295'}, {'value': '6.275', 'groupId': 'OG001', 'lowerLimit': '5.07', 'upperLimit': '6.51'}, {'value': '4.185', 'groupId': 'OG002', 'lowerLimit': '3.39', 'upperLimit': '6.16'}, {'value': '4.93', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '6.16'}]}]}, {'title': 'CD4+FOXP3+CD45RA+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '8.53', 'upperLimit': '28.9'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '9.79', 'upperLimit': '29.1'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '14.4', 'upperLimit': '29.25'}, {'value': '16.2', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': '25.4'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR+ICOS+PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1299', 'groupId': 'OG000', 'lowerLimit': '0.0785', 'upperLimit': '1.769'}, {'value': '0.0702', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.122'}, {'value': '0.1755', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '0.3'}, {'value': '0.113', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.261'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR+ICOS-PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1191', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.2565'}, {'value': '0.119', 'groupId': 'OG001', 'lowerLimit': '0.0747', 'upperLimit': '0.134'}, {'value': '0.0762', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.189'}, {'value': '0.0885', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.158'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR+ICOS-PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.9705', 'groupId': 'OG000', 'lowerLimit': '0.1534', 'upperLimit': '1.95'}, {'value': '0.2905', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.528'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '0.232', 'upperLimit': '0.902'}, {'value': '0.388', 'groupId': 'OG003', 'lowerLimit': '0.09', 'upperLimit': '0.567'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR-ICOS+PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1836', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.4805'}, {'value': '0.0637', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.112'}, {'value': '0.106', 'groupId': 'OG002', 'lowerLimit': '0.0339', 'upperLimit': '0.227'}, {'value': '0.092', 'groupId': 'OG003', 'lowerLimit': '0.0675', 'upperLimit': '0.3'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR-ICOS+PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3915', 'groupId': 'OG000', 'lowerLimit': '0.1665', 'upperLimit': '0.9885'}, {'value': '0.356', 'groupId': 'OG001', 'lowerLimit': '0.0747', 'upperLimit': '0.725'}, {'value': '0.74', 'groupId': 'OG002', 'lowerLimit': '0.244', 'upperLimit': '1.43'}, {'value': '0.3185', 'groupId': 'OG003', 'lowerLimit': '0.151', 'upperLimit': '0.68'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR-ICOS-PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0723', 'groupId': 'OG000', 'lowerLimit': '0.0327', 'upperLimit': '0.1541'}, {'value': '0.1245', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.18'}, {'value': '0.0972', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.182'}, {'value': '0.138', 'groupId': 'OG003', 'lowerLimit': '0.07', 'upperLimit': '0.358'}]}]}, {'title': 'CD4+FOXP3+CD45RA+HLADR-ICOS-PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '7.605', 'upperLimit': '23.3'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '8.82', 'upperLimit': '27.9'}, {'value': '15.985', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '24.85'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '9.04', 'upperLimit': '21.7'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR+ICOS+PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.629', 'groupId': 'OG000', 'lowerLimit': '0.1209', 'upperLimit': '1.27'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '3.42'}, {'value': '1.85', 'groupId': 'OG002', 'lowerLimit': '0.937', 'upperLimit': '2.93'}, {'value': '2.03', 'groupId': 'OG003', 'lowerLimit': '1.22', 'upperLimit': '4.61'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR+ICOS+PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '7.58', 'upperLimit': '27.7'}, {'value': '13.35', 'groupId': 'OG001', 'lowerLimit': '9.41', 'upperLimit': '20.7'}, {'value': '17.15', 'groupId': 'OG002', 'lowerLimit': '11.15', 'upperLimit': '24'}, {'value': '14.86', 'groupId': 'OG003', 'lowerLimit': '9.81', 'upperLimit': '19.4'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR+ICOS-PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5645', 'groupId': 'OG000', 'lowerLimit': '0.0596', 'upperLimit': '2.92'}, {'value': '0.478', 'groupId': 'OG001', 'lowerLimit': '0.234', 'upperLimit': '1.57'}, {'value': '0.651', 'groupId': 'OG002', 'lowerLimit': '0.177', 'upperLimit': '0.944'}, {'value': '1.03', 'groupId': 'OG003', 'lowerLimit': '0.49', 'upperLimit': '2.64'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR+ICOS-PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '7.21', 'upperLimit': '29.4'}, {'value': '5.065', 'groupId': 'OG001', 'lowerLimit': '3.31', 'upperLimit': '10.4'}, {'value': '7.16', 'groupId': 'OG002', 'lowerLimit': '4.72', 'upperLimit': '12.7'}, {'value': '11.6', 'groupId': 'OG003', 'lowerLimit': '4.37', 'upperLimit': '23.04'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR-ICOS+PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6269', 'groupId': 'OG000', 'lowerLimit': '0.0815', 'upperLimit': '1.82'}, {'value': '1.285', 'groupId': 'OG001', 'lowerLimit': '0.844', 'upperLimit': '2.17'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '2.14'}, {'value': '1.96', 'groupId': 'OG003', 'lowerLimit': '0.859', 'upperLimit': '3.43'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR-ICOS+PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.39', 'groupId': 'OG000', 'lowerLimit': '3.48', 'upperLimit': '8.345'}, {'value': '9.66', 'groupId': 'OG001', 'lowerLimit': '4.71', 'upperLimit': '22.1'}, {'value': '10.57', 'groupId': 'OG002', 'lowerLimit': '5.955', 'upperLimit': '16.035'}, {'value': '9.79', 'groupId': 'OG003', 'lowerLimit': '6.84', 'upperLimit': '14.4'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR-ICOS-PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7075', 'groupId': 'OG000', 'lowerLimit': '0.2181', 'upperLimit': '6.6895'}, {'value': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.43', 'upperLimit': '3.45'}, {'value': '1.815', 'groupId': 'OG002', 'lowerLimit': '0.51', 'upperLimit': '2.88'}, {'value': '3.28', 'groupId': 'OG003', 'lowerLimit': '1.77', 'upperLimit': '4.67'}]}]}, {'title': 'CD4+FOXP3+CD45RA-HLADR-ICOS-PD1-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.85', 'groupId': 'OG000', 'lowerLimit': '21.35', 'upperLimit': '44.5'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '41.9'}, {'value': '29.85', 'groupId': 'OG002', 'lowerLimit': '24.065', 'upperLimit': '38.4'}, {'value': '33.2', 'groupId': 'OG003', 'lowerLimit': '22.1', 'upperLimit': '36.4'}]}]}, {'title': 'CD4+FOXP3+HLADR+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '25.025', 'upperLimit': '56'}, {'value': '25.75', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '35.5'}, {'value': '31.65', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '40'}, {'value': '36.6', 'groupId': 'OG003', 'lowerLimit': '19.5', 'upperLimit': '47.94'}]}]}, {'title': 'CD4+FOXP3+ICOS+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '16.35', 'upperLimit': '38.1'}, {'value': '41.1', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '51.5'}, {'value': '33.795', 'groupId': 'OG002', 'lowerLimit': '21.6', 'upperLimit': '48.5'}, {'value': '35.3', 'groupId': 'OG003', 'lowerLimit': '24.3', 'upperLimit': '38.67'}]}]}, {'title': 'CD4+FOXP3+PD1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.505', 'groupId': 'OG000', 'lowerLimit': '1.3975', 'upperLimit': '13.225'}, {'value': '8.465', 'groupId': 'OG001', 'lowerLimit': '7.04', 'upperLimit': '12'}, {'value': '6.98', 'groupId': 'OG002', 'lowerLimit': '3.57', 'upperLimit': '10.45'}, {'value': '9.61', 'groupId': 'OG003', 'lowerLimit': '7.08', 'upperLimit': '17.1'}]}]}, {'title': 'CD4+polypositives FOXP3+CD45RA+HLADR+ICOS+PD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1167', 'groupId': 'OG000', 'lowerLimit': '0.0556', 'upperLimit': '0.46'}, {'value': '0.209', 'groupId': 'OG001', 'lowerLimit': '0.0804', 'upperLimit': '0.36'}, {'value': '0.1645', 'groupId': 'OG002', 'lowerLimit': '0.0894', 'upperLimit': '0.25'}, {'value': '0.1935', 'groupId': 'OG003', 'lowerLimit': '0.0675', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3-', 'categories': [{'measurements': [{'value': '94.95', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '95.45'}, {'value': '93.75', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '94.9'}, {'value': '95.88', 'groupId': 'OG002', 'lowerLimit': '93.8', 'upperLimit': '96.61'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '93.8', 'upperLimit': '96'}]}]}, {'title': 'CD4+FOXP3-CD45RA+', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '23.69', 'upperLimit': '41.75'}, {'value': '44.3', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '57.7'}, {'value': '33.9', 'groupId': 'OG002', 'lowerLimit': '22.13', 'upperLimit': '41.6'}, {'value': '30.2', 'groupId': 'OG003', 'lowerLimit': '16.47', 'upperLimit': '41.07'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR+ICOS+PD1-', 'categories': [{'measurements': [{'value': '0.0995', 'groupId': 'OG000', 'lowerLimit': '0.046', 'upperLimit': '0.2155'}, {'value': '0.1103', 'groupId': 'OG001', 'lowerLimit': '0.0519', 'upperLimit': '0.167'}, {'value': '0.0853', 'groupId': 'OG002', 'lowerLimit': '0.0346', 'upperLimit': '0.1865'}, {'value': '0.0297', 'groupId': 'OG003', 'lowerLimit': '0.004', 'upperLimit': '0.115'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR+ICOS-PD1+', 'categories': [{'measurements': [{'value': '0.2825', 'groupId': 'OG000', 'lowerLimit': '0.127', 'upperLimit': '0.4995'}, {'value': '0.1695', 'groupId': 'OG001', 'lowerLimit': '0.123', 'upperLimit': '0.369'}, {'value': '0.267', 'groupId': 'OG002', 'lowerLimit': '0.109', 'upperLimit': '0.983'}, {'value': '0.232', 'groupId': 'OG003', 'lowerLimit': '0.147', 'upperLimit': '0.857'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR+ICOS-PD1-', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '0.7938', 'upperLimit': '1.68'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '0.951', 'upperLimit': '3.3'}, {'value': '1.71', 'groupId': 'OG002', 'lowerLimit': '0.406', 'upperLimit': '2.805'}, {'value': '1.07', 'groupId': 'OG003', 'lowerLimit': '0.424', 'upperLimit': '1.89'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR-ICOS+PD1+', 'categories': [{'measurements': [{'value': '0.0895', 'groupId': 'OG000', 'lowerLimit': '0.0265', 'upperLimit': '0.346'}, {'value': '0.0928', 'groupId': 'OG001', 'lowerLimit': '0.0569', 'upperLimit': '0.141'}, {'value': '0.0873', 'groupId': 'OG002', 'lowerLimit': '0.0413', 'upperLimit': '0.3565'}, {'value': '0.0976', 'groupId': 'OG003', 'lowerLimit': '0.0273', 'upperLimit': '0.598'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR-ICOS+PD1-', 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '0.6668', 'upperLimit': '3.695'}, {'value': '1.84', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '3.52'}, {'value': '0.973', 'groupId': 'OG002', 'lowerLimit': '0.325', 'upperLimit': '2.895'}, {'value': '0.357', 'groupId': 'OG003', 'lowerLimit': '0.0525', 'upperLimit': '0.957'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR-ICOS-PD1+', 'categories': [{'measurements': [{'value': '0.174', 'groupId': 'OG000', 'lowerLimit': '0.1254', 'upperLimit': '0.3645'}, {'value': '0.193', 'groupId': 'OG001', 'lowerLimit': '0.0875', 'upperLimit': '1.15'}, {'value': '0.2585', 'groupId': 'OG002', 'lowerLimit': '0.126', 'upperLimit': '4.37'}, {'value': '0.368', 'groupId': 'OG003', 'lowerLimit': '0.0837', 'upperLimit': '12.58'}]}]}, {'title': 'CD4+FOXP3-CD45RA+HLADR-ICOS-PD1-', 'categories': [{'measurements': [{'value': '32.15', 'groupId': 'OG000', 'lowerLimit': '18.68', 'upperLimit': '38'}, {'value': '36.95', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '54.5'}, {'value': '23.8', 'groupId': 'OG002', 'lowerLimit': '10.64', 'upperLimit': '31.75'}, {'value': '14.96', 'groupId': 'OG003', 'lowerLimit': '4.58', 'upperLimit': '26.8'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR+ICOS+PD1+', 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '0.8255', 'upperLimit': '1.935'}, {'value': '0.995', 'groupId': 'OG001', 'lowerLimit': '0.469', 'upperLimit': '1.54'}, {'value': '1.026', 'groupId': 'OG002', 'lowerLimit': '0.3795', 'upperLimit': '1.835'}, {'value': '0.994', 'groupId': 'OG003', 'lowerLimit': '0.549', 'upperLimit': '1.96'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR+ICOS+PD1-', 'categories': [{'measurements': [{'value': '1.515', 'groupId': 'OG000', 'lowerLimit': '0.6425', 'upperLimit': '2.11'}, {'value': '0.727', 'groupId': 'OG001', 'lowerLimit': '0.567', 'upperLimit': '0.903'}, {'value': '0.789', 'groupId': 'OG002', 'lowerLimit': '0.352', 'upperLimit': '1.51'}, {'value': '0.522', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '1.48'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR+ICOS-PD1+', 'categories': [{'measurements': [{'value': '1.065', 'groupId': 'OG000', 'lowerLimit': '0.944', 'upperLimit': '1.23'}, {'value': '0.8265', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '1.28'}, {'value': '0.8765', 'groupId': 'OG002', 'lowerLimit': '0.3965', 'upperLimit': '2'}, {'value': '1.34', 'groupId': 'OG003', 'lowerLimit': '0.837', 'upperLimit': '2.51'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR+ICOS-PD1-', 'categories': [{'measurements': [{'value': '1.755', 'groupId': 'OG000', 'lowerLimit': '1.2135', 'upperLimit': '2.83'}, {'value': '0.979', 'groupId': 'OG001', 'lowerLimit': '0.571', 'upperLimit': '1.52'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '0.591', 'upperLimit': '2.805'}, {'value': '0.989', 'groupId': 'OG003', 'lowerLimit': '0.07', 'upperLimit': '4.27'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR-ICOS+PD1+', 'categories': [{'measurements': [{'value': '1.935', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '5.78'}, {'value': '2.28', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '3.28'}, {'value': '2.485', 'groupId': 'OG002', 'lowerLimit': '1.17', 'upperLimit': '7.05'}, {'value': '3.02', 'groupId': 'OG003', 'lowerLimit': '1.66', 'upperLimit': '9.15'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR-ICOS+PD1-', 'categories': [{'measurements': [{'value': '7.985', 'groupId': 'OG000', 'lowerLimit': '4.65', 'upperLimit': '13.555'}, {'value': '8.835', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': '12'}, {'value': '7.965', 'groupId': 'OG002', 'lowerLimit': '4.25', 'upperLimit': '14'}, {'value': '5.95', 'groupId': 'OG003', 'lowerLimit': '0.11', 'upperLimit': '9.55'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR-ICOS-PD1+', 'categories': [{'measurements': [{'value': '8.21', 'groupId': 'OG000', 'lowerLimit': '4.49', 'upperLimit': '10.285'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '3.88', 'upperLimit': '11.8'}, {'value': '7.385', 'groupId': 'OG002', 'lowerLimit': '3.62', 'upperLimit': '13.25'}, {'value': '14.1', 'groupId': 'OG003', 'lowerLimit': '7.07', 'upperLimit': '24.5'}]}]}, {'title': 'CD4+FOXP3-CD45RA-HLADR-ICOS-PD1-', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '27.95', 'upperLimit': '54.7'}, {'value': '27.95', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '40.8'}, {'value': '34.8', 'groupId': 'OG002', 'lowerLimit': '19.6', 'upperLimit': '43.425'}, {'value': '37.7', 'groupId': 'OG003', 'lowerLimit': '16.8', 'upperLimit': '52.6'}]}]}, {'title': 'CD4+FOXP3-HLADR+', 'categories': [{'measurements': [{'value': '7.845', 'groupId': 'OG000', 'lowerLimit': '5.62', 'upperLimit': '9.685'}, {'value': '6.22', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '7.11'}, {'value': '8.66', 'groupId': 'OG002', 'lowerLimit': '5.26', 'upperLimit': '10.95'}, {'value': '7.65', 'groupId': 'OG003', 'lowerLimit': '5.92', 'upperLimit': '11.9'}]}]}, {'title': 'CD4+FOXP3-ICOS+', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '8.77', 'upperLimit': '27.3'}, {'value': '16.95', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '18.5'}, {'value': '21.03', 'groupId': 'OG002', 'lowerLimit': '8.915', 'upperLimit': '32.525'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '8.85', 'upperLimit': '21.34'}]}]}, {'title': 'CD4+FOXP3-PD1+', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '10.565', 'upperLimit': '18'}, {'value': '9.895', 'groupId': 'OG001', 'lowerLimit': '9.12', 'upperLimit': '21'}, {'value': '14.17', 'groupId': 'OG002', 'lowerLimit': '8.025', 'upperLimit': '40.88'}, {'value': '20.3', 'groupId': 'OG003', 'lowerLimit': '13.9', 'upperLimit': '59.51'}]}]}, {'title': 'CD4+polypositives FOXP3-CD45RA+HLADR+ICOS+PD1', 'categories': [{'measurements': [{'value': '0.0998', 'groupId': 'OG000', 'lowerLimit': '0.0562', 'upperLimit': '0.1525'}, {'value': '0.069', 'groupId': 'OG001', 'lowerLimit': '0.0394', 'upperLimit': '0.148'}, {'value': '0.0689', 'groupId': 'OG002', 'lowerLimit': '0.0377', 'upperLimit': '0.2355'}, {'value': '0.0431', 'groupId': 'OG003', 'lowerLimit': '0.028', 'upperLimit': '0.124'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.335', 'groupId': 'OG000', 'lowerLimit': '3.875', 'upperLimit': '7.105'}, {'value': '5.82', 'groupId': 'OG001', 'lowerLimit': '5.62', 'upperLimit': '6.8'}, {'value': '4.68', 'groupId': 'OG002', 'lowerLimit': '3.77', 'upperLimit': '5.97'}, {'value': '5.37', 'groupId': 'OG003', 'lowerLimit': '4.18', 'upperLimit': '6.24'}]}]}, {'title': 'CD4+FOXP3+CD45RA+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.85', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '22.2'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '32.8'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '27.34'}, {'value': '16.5', 'groupId': 'OG003', 'lowerLimit': '8.58', 'upperLimit': '29.3'}]}]}, {'title': 'CD4+FOXP3+CD45RA+GITR+KI67-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2955', 'groupId': 'OG000', 'lowerLimit': '0.0861', 'upperLimit': '1.1145'}, {'value': '0.429', 'groupId': 'OG001', 'lowerLimit': '0.211', 'upperLimit': '0.571'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '0.269', 'upperLimit': '0.74'}, {'value': '0.399', 'groupId': 'OG003', 'lowerLimit': '0.288', 'upperLimit': '0.599'}]}]}, {'title': 'CD4+FOXP3+CD45RA+GITR-KI67+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0985', 'groupId': 'OG000', 'lowerLimit': '0.0663', 'upperLimit': '0.218'}, {'value': '0.2085', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.564'}, {'value': '0.234', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.448'}, {'value': '0.267', 'groupId': 'OG003', 'lowerLimit': '0.07', 'upperLimit': '0.452'}]}]}, {'title': 'CD4+FOXP3+CD45RA+GITR-KI67-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.55', 'groupId': 'OG000', 'lowerLimit': '10.75', 'upperLimit': '20.55'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '29.9'}, {'value': '17.7', 'groupId': 'OG002', 'lowerLimit': '13.1', 'upperLimit': '25.7'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '7.34', 'upperLimit': '27.93'}]}]}, {'title': 'CD4+FOXP3+CD45RA-GITR+KI67+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.26', 'groupId': 'OG000', 'lowerLimit': '7.055', 'upperLimit': '11.05'}, {'value': '8.24', 'groupId': 'OG001', 'lowerLimit': '4.47', 'upperLimit': '10.4'}, {'value': '8.14', 'groupId': 'OG002', 'lowerLimit': '6.32', 'upperLimit': '11.32'}, {'value': '7.43', 'groupId': 'OG003', 'lowerLimit': '5.09', 'upperLimit': '9.56'}]}]}, {'title': 'CD4+FOXP3+CD45RA-GITR+KI67-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.65', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '43.5'}, {'value': '33.4', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '45.2'}, {'value': '27.34', 'groupId': 'OG002', 'lowerLimit': '22.3', 'upperLimit': '34.18'}, {'value': '28.8', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '36.63'}]}]}, {'title': 'CD4+FOXP3+CD45RA-GITR-KI67+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.84', 'groupId': 'OG000', 'lowerLimit': '3.44', 'upperLimit': '7.11'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2.58', 'upperLimit': '5.58'}, {'value': '4.69', 'groupId': 'OG002', 'lowerLimit': '3.88', 'upperLimit': '6.77'}, {'value': '4.27', 'groupId': 'OG003', 'lowerLimit': '3.67', 'upperLimit': '6.19'}]}]}, {'title': 'CD4+FOXP3+CD45RA-GITR-KI67-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '45.3'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '36.7'}, {'value': '37.1', 'groupId': 'OG002', 'lowerLimit': '28.1', 'upperLimit': '42.6'}, {'value': '41.4', 'groupId': 'OG003', 'lowerLimit': '36', 'upperLimit': '47'}]}]}, {'title': 'CD4+FOXP3+GITR+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '34.95', 'upperLimit': '55'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '57.4'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '30.51', 'upperLimit': '46'}, {'value': '36.9', 'groupId': 'OG003', 'lowerLimit': '25.6', 'upperLimit': '45.6'}]}]}, {'title': 'CD4+FOXP3+KI67+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.95', 'groupId': 'OG000', 'lowerLimit': '12.25', 'upperLimit': '17.25'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '8.14', 'upperLimit': '15.7'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '10.89', 'upperLimit': '18.9'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '9.49', 'upperLimit': '16.5'}]}]}, {'title': 'CD4+polypositives FOXP3+CD45RA+GITR+KI67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2685', 'groupId': 'OG000', 'lowerLimit': '0.1568', 'upperLimit': '0.4415'}, {'value': '0.1855', 'groupId': 'OG001', 'lowerLimit': '0.0945', 'upperLimit': '0.42'}, {'value': '0.331', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.53'}, {'value': '0.28', 'groupId': 'OG003', 'lowerLimit': '0.175', 'upperLimit': '0.512'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3-', 'categories': [{'measurements': [{'value': '94.65', 'groupId': 'OG000', 'lowerLimit': '92.85', 'upperLimit': '96.15'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '94.4'}, {'value': '95.31', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '96.2'}, {'value': '94.65', 'groupId': 'OG003', 'lowerLimit': '93.75', 'upperLimit': '95.85'}]}]}, {'title': 'CD4+FOXP3-CD45RA+', 'categories': [{'measurements': [{'value': '45.95', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '49.25'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '29.4', 'upperLimit': '56.5'}, {'value': '34.3', 'groupId': 'OG002', 'lowerLimit': '26.7', 'upperLimit': '44.3'}, {'value': '33.4', 'groupId': 'OG003', 'lowerLimit': '24.295', 'upperLimit': '43.4'}]}]}, {'title': 'CD4+FOXP3-CD45RA+GITR+KI67-', 'categories': [{'measurements': [{'value': '0.6515', 'groupId': 'OG000', 'lowerLimit': '0.4665', 'upperLimit': '5.7485'}, {'value': '0.567', 'groupId': 'OG001', 'lowerLimit': '0.359', 'upperLimit': '0.891'}, {'value': '0.609', 'groupId': 'OG002', 'lowerLimit': '0.27', 'upperLimit': '2.23'}, {'value': '0.563', 'groupId': 'OG003', 'lowerLimit': '0.3155', 'upperLimit': '1.46'}]}]}, {'title': 'CD4+FOXP3-CD45RA+GITR-KI67+', 'categories': [{'measurements': [{'value': '0.328', 'groupId': 'OG000', 'lowerLimit': '0.226', 'upperLimit': '0.393'}, {'value': '0.365', 'groupId': 'OG001', 'lowerLimit': '0.332', 'upperLimit': '0.685'}, {'value': '0.251', 'groupId': 'OG002', 'lowerLimit': '0.142', 'upperLimit': '0.404'}, {'value': '0.2275', 'groupId': 'OG003', 'lowerLimit': '0.166', 'upperLimit': '0.471'}]}]}, {'title': 'CD4+FOXP3-CD45RA+GITR-KI67-', 'categories': [{'measurements': [{'value': '42.85', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': '48.25'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '55.2'}, {'value': '30.14', 'groupId': 'OG002', 'lowerLimit': '14.15', 'upperLimit': '41.1'}, {'value': '30.3', 'groupId': 'OG003', 'lowerLimit': '19.95', 'upperLimit': '37.9'}]}]}, {'title': 'CD4+FOXP3-CD45RA-GITR+KI67+', 'categories': [{'measurements': [{'value': '1.0535', 'groupId': 'OG000', 'lowerLimit': '0.583', 'upperLimit': '1.38'}, {'value': '0.566', 'groupId': 'OG001', 'lowerLimit': '0.472', 'upperLimit': '0.974'}, {'value': '0.854', 'groupId': 'OG002', 'lowerLimit': '0.528', 'upperLimit': '1.46'}, {'value': '0.7955', 'groupId': 'OG003', 'lowerLimit': '0.5645', 'upperLimit': '1.27'}]}]}, {'title': 'CD4+FOXP3-CD45RA-GITR+KI67-', 'categories': [{'measurements': [{'value': '13.35', 'groupId': 'OG000', 'lowerLimit': '8.36', 'upperLimit': '19.25'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '4.34', 'upperLimit': '15.6'}, {'value': '12.94', 'groupId': 'OG002', 'lowerLimit': '7.33', 'upperLimit': '16.51'}, {'value': '13.225', 'groupId': 'OG003', 'lowerLimit': '9.03', 'upperLimit': '14.95'}]}]}, {'title': 'CD4+FOXP3-CD45RA-GITR-KI67+', 'categories': [{'measurements': [{'value': '1.575', 'groupId': 'OG000', 'lowerLimit': '1.405', 'upperLimit': '2.05'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '2.44'}, {'value': '1.83', 'groupId': 'OG002', 'lowerLimit': '1.29', 'upperLimit': '2.24'}, {'value': '1.455', 'groupId': 'OG003', 'lowerLimit': '1.053', 'upperLimit': '2.175'}]}]}, {'title': 'CD4+FOXP3-CD45RA-GITR-KI67-', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '45.8'}, {'value': '43.7', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '52.6'}, {'value': '49.1', 'groupId': 'OG002', 'lowerLimit': '40.7', 'upperLimit': '58.5'}, {'value': '50.9', 'groupId': 'OG003', 'lowerLimit': '38.55', 'upperLimit': '59.655'}]}]}, {'title': 'CD4+FOXP3-GITR+', 'categories': [{'measurements': [{'value': '15.05', 'groupId': 'OG000', 'lowerLimit': '9.585', 'upperLimit': '26.7'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '5.88', 'upperLimit': '17.1'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '8.49', 'upperLimit': '19.72'}, {'value': '15.7', 'groupId': 'OG003', 'lowerLimit': '10.155', 'upperLimit': '17.65'}]}]}, {'title': 'CD4+FOXP3-KI67+', 'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '2.47', 'upperLimit': '3.98'}, {'value': '3.42', 'groupId': 'OG001', 'lowerLimit': '2.32', 'upperLimit': '4'}, {'value': '3.32', 'groupId': 'OG002', 'lowerLimit': '2.43', 'upperLimit': '4.57'}, {'value': '3.28', 'groupId': 'OG003', 'lowerLimit': '2.06', 'upperLimit': '3.76'}]}]}, {'title': 'CD4+polypositives FOXP3-CD45RA+GITR+KI67', 'categories': [{'measurements': [{'value': '0.1275', 'groupId': 'OG000', 'lowerLimit': '0.0874', 'upperLimit': '0.331'}, {'value': '0.0944', 'groupId': 'OG001', 'lowerLimit': '0.081', 'upperLimit': '0.162'}, {'value': '0.0945', 'groupId': 'OG002', 'lowerLimit': '0.049', 'upperLimit': '0.202'}, {'value': '0.0901', 'groupId': 'OG003', 'lowerLimit': '0.0717', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.12', 'groupId': 'OG000', 'lowerLimit': '3.33', 'upperLimit': '5.14'}, {'value': '5.48', 'groupId': 'OG001', 'lowerLimit': '4.56', 'upperLimit': '6.07'}, {'value': '4.26', 'groupId': 'OG002', 'lowerLimit': '3.19', 'upperLimit': '6'}, {'value': '4.64', 'groupId': 'OG003', 'lowerLimit': '2.87', 'upperLimit': '5.22'}]}]}, {'title': 'CD4+FOXP3+CCR7+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.15', 'groupId': 'OG000', 'lowerLimit': '38.45', 'upperLimit': '50.9'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '35.1', 'upperLimit': '61.1'}, {'value': '54.065', 'groupId': 'OG002', 'lowerLimit': '43.54', 'upperLimit': '59.75'}, {'value': '42.4', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '55.9'}]}]}, {'title': 'CD4+FOXP3+CCR7+CD45RA+CD62L-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4295', 'groupId': 'OG000', 'lowerLimit': '0.1971', 'upperLimit': '0.515'}, {'value': '0.2005', 'groupId': 'OG001', 'lowerLimit': '0.0747', 'upperLimit': '0.366'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.0485', 'upperLimit': '0.307'}, {'value': '0.105', 'groupId': 'OG003', 'lowerLimit': '0.0676', 'upperLimit': '0.364'}]}]}, {'title': 'CD4+FOXP3+CCR7+CD45RA-CD62L+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.85', 'groupId': 'OG000', 'lowerLimit': '21.45', 'upperLimit': '33.35'}, {'value': '30.1', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '32.6'}, {'value': '34.66', 'groupId': 'OG002', 'lowerLimit': '27.24', 'upperLimit': '39.24'}, {'value': '25.65', 'groupId': 'OG003', 'lowerLimit': '21.4', 'upperLimit': '31.7'}]}]}, {'title': 'CD4+FOXP3+CCR7+CD45RA-CD62L-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.027', 'upperLimit': '3.11'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '4.86'}, {'value': '1.88', 'groupId': 'OG002', 'lowerLimit': '1.18', 'upperLimit': '2.83'}, {'value': '2.065', 'groupId': 'OG003', 'lowerLimit': '1.63', 'upperLimit': '2.76'}]}]}, {'title': 'CD4+FOXP3+CCR7-CD45RA+CD62L+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.909', 'groupId': 'OG000', 'lowerLimit': '0.2809', 'upperLimit': '2.32'}, {'value': '0.522', 'groupId': 'OG001', 'lowerLimit': '0.224', 'upperLimit': '2.14'}, {'value': '0.59', 'groupId': 'OG002', 'lowerLimit': '0.315', 'upperLimit': '1.13'}, {'value': '0.8925', 'groupId': 'OG003', 'lowerLimit': '0.36', 'upperLimit': '1.94'}]}]}, {'title': 'CD4+FOXP3+CCR7-CD45RA+CD62L-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0502', 'groupId': 'OG000', 'lowerLimit': '0.022', 'upperLimit': '0.0671'}, {'value': '0.0732', 'groupId': 'OG001', 'lowerLimit': '0.0249', 'upperLimit': '0.142'}, {'value': '0.0499', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0805'}, {'value': '0.075', 'groupId': 'OG003', 'lowerLimit': '0.0277', 'upperLimit': '0.14'}]}]}, {'title': 'CD4+FOXP3+CCR7-CD45RA-CD62L+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '34.85', 'upperLimit': '51.85'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '43.5'}, {'value': '37.7', 'groupId': 'OG002', 'lowerLimit': '32.9', 'upperLimit': '44.35'}, {'value': '42.5', 'groupId': 'OG003', 'lowerLimit': '32.6', 'upperLimit': '56.08'}]}]}, {'title': 'CD4+FOXP3+CCR7-CD45RA-CD62L-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '7.19', 'upperLimit': '13.9'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '6.19', 'upperLimit': '16.8'}, {'value': '6.56', 'groupId': 'OG002', 'lowerLimit': '4.805', 'upperLimit': '10.06'}, {'value': '8.985', 'groupId': 'OG003', 'lowerLimit': '6.93', 'upperLimit': '15.9'}]}]}, {'title': 'CD4+FOXP3+CD45RA+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '19.65'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8.64', 'upperLimit': '31.2'}, {'value': '16.95', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '23'}, {'value': '14.25', 'groupId': 'OG003', 'lowerLimit': '8.43', 'upperLimit': '19.48'}]}]}, {'title': 'CD4+FOXP3+CD62L+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.55', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '91.05'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '77.7', 'upperLimit': '92.2'}, {'value': '90.85', 'groupId': 'OG002', 'lowerLimit': '87.005', 'upperLimit': '93.45'}, {'value': '88.2', 'groupId': 'OG003', 'lowerLimit': '78.3', 'upperLimit': '91.2'}]}]}, {'title': 'CD4+polypositives FOXP3+CCR7+CD45RA+CD62L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.25', 'groupId': 'OG000', 'lowerLimit': '11.295', 'upperLimit': '18.4'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '5.76', 'upperLimit': '28.6'}, {'value': '15.1', 'groupId': 'OG002', 'lowerLimit': '11.25', 'upperLimit': '21.4'}, {'value': '11.95', 'groupId': 'OG003', 'lowerLimit': '6.42', 'upperLimit': '15.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3-', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '94.85', 'upperLimit': '96.7'}, {'value': '94.4', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '95.4'}, {'value': '95.73', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '96.8'}, {'value': '95.4', 'groupId': 'OG003', 'lowerLimit': '94.8', 'upperLimit': '97.1'}]}]}, {'title': 'CD4+FOXP3-CCR7+', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '84.1'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '91.6'}, {'value': '76.1', 'groupId': 'OG002', 'lowerLimit': '67.8', 'upperLimit': '83.2'}, {'value': '70.8', 'groupId': 'OG003', 'lowerLimit': '56.8', 'upperLimit': '82.1'}]}]}, {'title': 'CD4+FOXP3-CCR7+CD45RA+CD62L-', 'categories': [{'measurements': [{'value': '0.4295', 'groupId': 'OG000', 'lowerLimit': '0.1966', 'upperLimit': '0.6885'}, {'value': '0.474', 'groupId': 'OG001', 'lowerLimit': '0.259', 'upperLimit': '0.664'}, {'value': '0.305', 'groupId': 'OG002', 'lowerLimit': '0.187', 'upperLimit': '0.58'}, {'value': '0.272', 'groupId': 'OG003', 'lowerLimit': '0.196', 'upperLimit': '1.03'}]}]}, {'title': 'CD4+FOXP3-CCR7+CD45RA-CD62L+', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '25.45', 'upperLimit': '38.3'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '24.5', 'upperLimit': '31.7'}, {'value': '34.7', 'groupId': 'OG002', 'lowerLimit': '26.7', 'upperLimit': '40.32'}, {'value': '33.4', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': '36.04'}]}]}, {'title': 'CD4+FOXP3-CCR7+CD45RA-CD62L-', 'categories': [{'measurements': [{'value': '5.79', 'groupId': 'OG000', 'lowerLimit': '3.915', 'upperLimit': '7.415'}, {'value': '4.09', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '5.84'}, {'value': '4.35', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '6.33'}, {'value': '5.16', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '8.58'}]}]}, {'title': 'CD4+FOXP3-CCR7-CD45RA+CD62L+', 'categories': [{'measurements': [{'value': '1.005', 'groupId': 'OG000', 'lowerLimit': '0.388', 'upperLimit': '1.485'}, {'value': '0.755', 'groupId': 'OG001', 'lowerLimit': '0.259', 'upperLimit': '2.1'}, {'value': '0.719', 'groupId': 'OG002', 'lowerLimit': '0.469', 'upperLimit': '2.36'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.415', 'upperLimit': '2.12'}]}]}, {'title': 'CD4+FOXP3-CCR7-CD45RA+CD62L-', 'categories': [{'measurements': [{'value': '1.2035', 'groupId': 'OG000', 'lowerLimit': '0.594', 'upperLimit': '2.06'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '0.688', 'upperLimit': '2.08'}, {'value': '0.82', 'groupId': 'OG002', 'lowerLimit': '0.466', 'upperLimit': '1.88'}, {'value': '0.855', 'groupId': 'OG003', 'lowerLimit': '0.34', 'upperLimit': '1.22'}]}]}, {'title': 'CD4+FOXP3-CCR7-CD45RA-CD62L+', 'categories': [{'measurements': [{'value': '7.91', 'groupId': 'OG000', 'lowerLimit': '7.115', 'upperLimit': '11.19'}, {'value': '6.69', 'groupId': 'OG001', 'lowerLimit': '3.54', 'upperLimit': '9.01'}, {'value': '8.86', 'groupId': 'OG002', 'lowerLimit': '7.11', 'upperLimit': '12.22'}, {'value': '10.84', 'groupId': 'OG003', 'lowerLimit': '5.57', 'upperLimit': '16'}]}]}, {'title': 'CD4+FOXP3-CCR7-CD45RA-CD62L-', 'categories': [{'measurements': [{'value': '7.795', 'groupId': 'OG000', 'lowerLimit': '6.36', 'upperLimit': '11.38'}, {'value': '9.79', 'groupId': 'OG001', 'lowerLimit': '5.37', 'upperLimit': '14.7'}, {'value': '10.54', 'groupId': 'OG002', 'lowerLimit': '7.72', 'upperLimit': '15.7'}, {'value': '15.5', 'groupId': 'OG003', 'lowerLimit': '6.36', 'upperLimit': '18.6'}]}]}, {'title': 'CD4+FOXP3-CD45RA+', 'categories': [{'measurements': [{'value': '47.45', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '49.5'}, {'value': '47.2', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '49.7'}, {'value': '38.6', 'groupId': 'OG002', 'lowerLimit': '30.79', 'upperLimit': '48.05'}, {'value': '33.8', 'groupId': 'OG003', 'lowerLimit': '28.3', 'upperLimit': '46.92'}]}]}, {'title': 'CD4+FOXP3-CD62L+', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '85.95'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '77.1', 'upperLimit': '88.7'}, {'value': '83.6', 'groupId': 'OG002', 'lowerLimit': '76.4', 'upperLimit': '86.3'}, {'value': '75.3', 'groupId': 'OG003', 'lowerLimit': '72', 'upperLimit': '86'}]}]}, {'title': 'CD4+polypositives FOXP3-CCR7+CD45RA+CD62L', 'categories': [{'measurements': [{'value': '44.45', 'groupId': 'OG000', 'lowerLimit': '37.85', 'upperLimit': '45.65'}, {'value': '39.7', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '48.2'}, {'value': '35.56', 'groupId': 'OG002', 'lowerLimit': '26.4', 'upperLimit': '43.2'}, {'value': '32.1', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '41.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.375', 'groupId': 'OG000', 'lowerLimit': '3.745', 'upperLimit': '6.185'}, {'value': '5.68', 'groupId': 'OG001', 'lowerLimit': '4.84', 'upperLimit': '6.32'}, {'value': '4.415', 'groupId': 'OG002', 'lowerLimit': '3.195', 'upperLimit': '5.995'}, {'value': '5.32', 'groupId': 'OG003', 'lowerLimit': '3.98', 'upperLimit': '6.85'}]}]}, {'title': 'CD4+FOXP3+CD39+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.25', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '52.3'}, {'value': '54.7', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '65.5'}, {'value': '42.2', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '54.8'}, {'value': '46.9', 'groupId': 'OG003', 'lowerLimit': '32.9', 'upperLimit': '63.79'}]}]}, {'title': 'CD4+FOXP3+CD39+CD45RA+TNFR2-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0161'}, {'value': '0.0156', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.112'}, {'value': '0.0381', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0706'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0512'}]}]}, {'title': 'CD4+FOXP3+CD39+CD45RA-TNFR2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.55', 'groupId': 'OG000', 'lowerLimit': '27.75', 'upperLimit': '49.65'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '63.8'}, {'value': '39.85', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '50.49'}, {'value': '43.3', 'groupId': 'OG003', 'lowerLimit': '31.3', 'upperLimit': '61.6'}]}]}, {'title': 'CD4+FOXP3+CD39+CD45RA-TNFR2-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.133', 'upperLimit': '0.831'}, {'value': '0.165', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.352'}, {'value': '0.1915', 'groupId': 'OG002', 'lowerLimit': '0.0977', 'upperLimit': '0.6025'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.155', 'upperLimit': '0.502'}]}]}, {'title': 'CD4+FOXP3+CD39-CD45RA+TNFR2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '11.47', 'upperLimit': '17.45'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '8.25', 'upperLimit': '24.8'}, {'value': '17.075', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '21.3'}, {'value': '13.12', 'groupId': 'OG003', 'lowerLimit': '6.96', 'upperLimit': '18'}]}]}, {'title': 'CD4+FOXP3+CD39-CD45RA+TNFR2-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.009', 'groupId': 'OG000', 'lowerLimit': '0.5365', 'upperLimit': '1.325'}, {'value': '0.7245', 'groupId': 'OG001', 'lowerLimit': '0.497', 'upperLimit': '1.16'}, {'value': '0.815', 'groupId': 'OG002', 'lowerLimit': '0.48', 'upperLimit': '1.79'}, {'value': '0.658', 'groupId': 'OG003', 'lowerLimit': '0.155', 'upperLimit': '1.81'}]}]}, {'title': 'CD4+FOXP3+CD39-CD45RA-TNFR2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.25', 'groupId': 'OG000', 'lowerLimit': '30.15', 'upperLimit': '56.35'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '45.3'}, {'value': '37.685', 'groupId': 'OG002', 'lowerLimit': '28.4', 'upperLimit': '56.7'}, {'value': '32.01', 'groupId': 'OG003', 'lowerLimit': '24.4', 'upperLimit': '49'}]}]}, {'title': 'CD4+FOXP3+CD39-CD45RA-TNFR2-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.8705', 'groupId': 'OG000', 'lowerLimit': '0.7215', 'upperLimit': '1.256'}, {'value': '0.6765', 'groupId': 'OG001', 'lowerLimit': '0.448', 'upperLimit': '0.776'}, {'value': '1.085', 'groupId': 'OG002', 'lowerLimit': '0.628', 'upperLimit': '2.16'}, {'value': '0.702', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '1.84'}]}]}, {'title': 'CD4+FOXP3+CD45RA+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '20.05'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '9.32', 'upperLimit': '39.3'}, {'value': '19.75', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '24.5'}, {'value': '15.7', 'groupId': 'OG003', 'lowerLimit': '8.08', 'upperLimit': '21.6'}]}]}, {'title': 'CD4+FOXP3+TNFR2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '97.15', 'upperLimit': '98'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '98.6'}, {'value': '97.25', 'groupId': 'OG002', 'lowerLimit': '95.7', 'upperLimit': '98.6'}, {'value': '97.9', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '98.9'}]}]}, {'title': 'CD4+pol FOXP3+CD39+CD45RA+TNFR2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.2415', 'groupId': 'OG000', 'lowerLimit': '0.509', 'upperLimit': '1.805'}, {'value': '1.49', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '2.25'}, {'value': '1.215', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '2.03'}, {'value': '0.9295', 'groupId': 'OG003', 'lowerLimit': '0.593', 'upperLimit': '1.35'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3-', 'categories': [{'measurements': [{'value': '94.65', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '96.3'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '93.7', 'upperLimit': '95.2'}, {'value': '95.585', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '96.8'}, {'value': '94.7', 'groupId': 'OG003', 'lowerLimit': '93.2', 'upperLimit': '96'}]}]}, {'title': 'CD4+FOXP3-CD39+', 'categories': [{'measurements': [{'value': '3.395', 'groupId': 'OG000', 'lowerLimit': '2.82', 'upperLimit': '4.625'}, {'value': '3.93', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '5.16'}, {'value': '4.015', 'groupId': 'OG002', 'lowerLimit': '2.135', 'upperLimit': '5.34'}, {'value': '4.83', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '6.05'}]}]}, {'title': 'CD4+FOXP3-CD39+CD45RA+TNFR2-', 'categories': [{'measurements': [{'value': '0.828', 'groupId': 'OG000', 'lowerLimit': '0.4515', 'upperLimit': '1.41'}, {'value': '0.531', 'groupId': 'OG001', 'lowerLimit': '0.401', 'upperLimit': '0.698'}, {'value': '0.5295', 'groupId': 'OG002', 'lowerLimit': '0.352', 'upperLimit': '0.786'}, {'value': '0.46', 'groupId': 'OG003', 'lowerLimit': '0.31', 'upperLimit': '0.64'}]}]}, {'title': 'CD4+FOXP3-CD39+CD45RA-TNFR2+', 'categories': [{'measurements': [{'value': '1.965', 'groupId': 'OG000', 'lowerLimit': '0.936', 'upperLimit': '2.65'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '0.637', 'upperLimit': '2.91'}, {'value': '2.22', 'groupId': 'OG002', 'lowerLimit': '0.7095', 'upperLimit': '2.9'}, {'value': '3.24', 'groupId': 'OG003', 'lowerLimit': '1.85', 'upperLimit': '4.15'}]}]}, {'title': 'CD4+FOXP3-CD39+CD45RA-TNFR2-', 'categories': [{'measurements': [{'value': '0.6185', 'groupId': 'OG000', 'lowerLimit': '0.3685', 'upperLimit': '0.857'}, {'value': '0.754', 'groupId': 'OG001', 'lowerLimit': '0.133', 'upperLimit': '0.898'}, {'value': '0.6635', 'groupId': 'OG002', 'lowerLimit': '0.2125', 'upperLimit': '1.085'}, {'value': '0.749', 'groupId': 'OG003', 'lowerLimit': '0.547', 'upperLimit': '1.04'}]}]}, {'title': 'CD4+FOXP3-CD39-CD45RA+TNFR2+', 'categories': [{'measurements': [{'value': '2.66', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '4.095'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.2'}, {'value': '3.585', 'groupId': 'OG002', 'lowerLimit': '2.115', 'upperLimit': '4.485'}, {'value': '3.04', 'groupId': 'OG003', 'lowerLimit': '1.41', 'upperLimit': '3.77'}]}]}, {'title': 'CD4+FOXP3-CD39-CD45RA+TNFR2-', 'categories': [{'measurements': [{'value': '41.85', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '45.7'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '52.9'}, {'value': '36.41', 'groupId': 'OG002', 'lowerLimit': '29.9', 'upperLimit': '47.9'}, {'value': '29.9', 'groupId': 'OG003', 'lowerLimit': '24.3', 'upperLimit': '40.7'}]}]}, {'title': 'CD4+FOXP3-CD39-CD45RA-TNFR2+', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': '30.55'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '36.3'}, {'value': '32.155', 'groupId': 'OG002', 'lowerLimit': '24.21', 'upperLimit': '41.345'}, {'value': '38.9', 'groupId': 'OG003', 'lowerLimit': '26.2', 'upperLimit': '46.1'}]}]}, {'title': 'CD4+FOXP3-CD39-CD45RA-TNFR2-', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '26.5'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '23.1'}, {'value': '21.42', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '25.3'}, {'value': '20.9', 'groupId': 'OG003', 'lowerLimit': '17.95', 'upperLimit': '25.6'}]}]}, {'title': 'CD4+FOXP3-CD45RA+', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '40.15', 'upperLimit': '50.6'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '39.8', 'upperLimit': '55.3'}, {'value': '41.235', 'groupId': 'OG002', 'lowerLimit': '33.795', 'upperLimit': '52.195'}, {'value': '33.8', 'groupId': 'OG003', 'lowerLimit': '25.6', 'upperLimit': '47.44'}]}]}, {'title': 'CD4+FOXP3-TNFR2+', 'categories': [{'measurements': [{'value': '35.05', 'groupId': 'OG000', 'lowerLimit': '33.7', 'upperLimit': '36.4'}, {'value': '34.1', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '50.2'}, {'value': '39.23', 'groupId': 'OG002', 'lowerLimit': '29.55', 'upperLimit': '46.935'}, {'value': '45.6', 'groupId': 'OG003', 'lowerLimit': '33', 'upperLimit': '53.2'}]}]}, {'title': 'CD4+polypositives FOXP3-CD39+CD45RA+TNFR2', 'categories': [{'measurements': [{'value': '0.3485', 'groupId': 'OG000', 'lowerLimit': '0.209', 'upperLimit': '0.561'}, {'value': '0.252', 'groupId': 'OG001', 'lowerLimit': '0.173', 'upperLimit': '0.398'}, {'value': '0.2795', 'groupId': 'OG002', 'lowerLimit': '0.221', 'upperLimit': '0.472'}, {'value': '0.336', 'groupId': 'OG003', 'lowerLimit': '0.244', 'upperLimit': '0.478'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.555', 'groupId': 'OG000', 'lowerLimit': '1.8151', 'upperLimit': '8.095'}, {'value': '6.09', 'groupId': 'OG001', 'lowerLimit': '5.17', 'upperLimit': '6.73'}, {'value': '4.655', 'groupId': 'OG002', 'lowerLimit': '3.38', 'upperLimit': '6.145'}, {'value': '5.045', 'groupId': 'OG003', 'lowerLimit': '3.23', 'upperLimit': '5.98'}]}]}, {'title': 'CD4+FOXP3+CD45RA+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '19.7'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '7.16', 'upperLimit': '22.8'}, {'value': '18.5', 'groupId': 'OG002', 'lowerLimit': '13.01', 'upperLimit': '26.3'}, {'value': '16.6', 'groupId': 'OG003', 'lowerLimit': '8.81', 'upperLimit': '24.5'}]}]}, {'title': 'CD4+FOXP3+CD45RA+CTLA4+OX40-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '1.66'}, {'value': '1.75', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '2.63'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '2.35'}, {'value': '1.09', 'groupId': 'OG003', 'lowerLimit': '0.74', 'upperLimit': '2.4'}]}]}, {'title': 'CD4+FOXP3+CD45RA+CTLA4-OX40+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.107', 'groupId': 'OG000', 'lowerLimit': '0.0722', 'upperLimit': '0.26'}, {'value': '0.174', 'groupId': 'OG001', 'lowerLimit': '0.106', 'upperLimit': '0.205'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.06', 'upperLimit': '0.31'}, {'value': '0.126', 'groupId': 'OG003', 'lowerLimit': '0.06', 'upperLimit': '0.252'}]}]}, {'title': 'CD4+FOXP3+CD45RA+CTLA4-OX40-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '17.9'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '5.85', 'upperLimit': '20.9'}, {'value': '16.1', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '23.72'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '6.32', 'upperLimit': '21.9'}]}]}, {'title': 'CD4+FOXP3+CD45RA-CTLA4+OX40+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.53'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '4.04'}, {'value': '1.345', 'groupId': 'OG002', 'lowerLimit': '0.631', 'upperLimit': '2.13'}, {'value': '2.38', 'groupId': 'OG003', 'lowerLimit': '0.84', 'upperLimit': '4.15'}]}]}, {'title': 'CD4+FOXP3+CD45RA-CTLA4+OX40-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '30.4'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '47.4'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '15.9', 'upperLimit': '38.3'}, {'value': '31.7', 'groupId': 'OG003', 'lowerLimit': '28.08', 'upperLimit': '39.1'}]}]}, {'title': 'CD4+FOXP3+CD45RA-CTLA4-OX40+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.16', 'groupId': 'OG000', 'lowerLimit': '6.28', 'upperLimit': '11.9'}, {'value': '1.915', 'groupId': 'OG001', 'lowerLimit': '0.872', 'upperLimit': '3.26'}, {'value': '1.515', 'groupId': 'OG002', 'lowerLimit': '0.62', 'upperLimit': '2.54'}, {'value': '1.39', 'groupId': 'OG003', 'lowerLimit': '0.586', 'upperLimit': '1.98'}]}]}, {'title': 'CD4+FOXP3+CD45RA-CTLA4-OX40-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '47.5'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '47.3'}, {'value': '47.9', 'groupId': 'OG002', 'lowerLimit': '39.5', 'upperLimit': '56.2'}, {'value': '38.1', 'groupId': 'OG003', 'lowerLimit': '32.6', 'upperLimit': '49.3'}]}]}, {'title': 'CD4+FOXP3+CTLA4+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '27.9', 'upperLimit': '34.6'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '31.8', 'upperLimit': '53.5'}, {'value': '27.5', 'groupId': 'OG002', 'lowerLimit': '17.64', 'upperLimit': '40.9'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '32.1', 'upperLimit': '51.2'}]}]}, {'title': 'CD4+FOXP3+OX40+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.15', 'upperLimit': '14.7'}, {'value': '5.15', 'groupId': 'OG001', 'lowerLimit': '2.68', 'upperLimit': '6.51'}, {'value': '3.66', 'groupId': 'OG002', 'lowerLimit': '1.72', 'upperLimit': '6.15'}, {'value': '3.94', 'groupId': 'OG003', 'lowerLimit': '2.16', 'upperLimit': '7.55'}]}]}, {'title': 'CD4+polypositives FOXP3+CD45RA+CTLA4+OX40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.188', 'groupId': 'OG000', 'lowerLimit': '0.0722', 'upperLimit': '0.364'}, {'value': '0.118', 'groupId': 'OG001', 'lowerLimit': '0.0709', 'upperLimit': '0.381'}, {'value': '0.19', 'groupId': 'OG002', 'lowerLimit': '0.0322', 'upperLimit': '0.37'}, {'value': '0.283', 'groupId': 'OG003', 'lowerLimit': '0.0993', 'upperLimit': '0.503'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3-', 'categories': [{'measurements': [{'value': '94.45', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '98.2'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '94.8'}, {'value': '95.395', 'groupId': 'OG002', 'lowerLimit': '93.85', 'upperLimit': '96.645'}, {'value': '94.95', 'groupId': 'OG003', 'lowerLimit': '94', 'upperLimit': '96.8'}]}]}, {'title': 'CD4+FOXP3-CD45RA+', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '19.455', 'upperLimit': '52.1'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '37.1', 'upperLimit': '53'}, {'value': '36.05', 'groupId': 'OG002', 'lowerLimit': '24.055', 'upperLimit': '46.25'}, {'value': '31.55', 'groupId': 'OG003', 'lowerLimit': '22.2', 'upperLimit': '38.9'}]}]}, {'title': 'CD4+FOXP3-CD45RA+CTLA4+OX40-', 'categories': [{'measurements': [{'value': '0.2755', 'groupId': 'OG000', 'lowerLimit': '0.0746', 'upperLimit': '0.411'}, {'value': '0.263', 'groupId': 'OG001', 'lowerLimit': '0.212', 'upperLimit': '0.456'}, {'value': '0.2505', 'groupId': 'OG002', 'lowerLimit': '0.0902', 'upperLimit': '0.4915'}, {'value': '0.265', 'groupId': 'OG003', 'lowerLimit': '0.0806', 'upperLimit': '0.475'}]}]}, {'title': 'CD4+FOXP3-CD45RA+CTLA4-OX40+', 'categories': [{'measurements': [{'value': '0.1715', 'groupId': 'OG000', 'lowerLimit': '0.0816', 'upperLimit': '0.1975'}, {'value': '0.287', 'groupId': 'OG001', 'lowerLimit': '0.128', 'upperLimit': '0.488'}, {'value': '0.1645', 'groupId': 'OG002', 'lowerLimit': '0.0503', 'upperLimit': '0.5495'}, {'value': '0.243', 'groupId': 'OG003', 'lowerLimit': '0.11', 'upperLimit': '0.519'}]}]}, {'title': 'CD4+FOXP3-CD45RA+CTLA4-OX40-', 'categories': [{'measurements': [{'value': '44.55', 'groupId': 'OG000', 'lowerLimit': '18.9001', 'upperLimit': '51.55'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '52'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '23.4', 'upperLimit': '44.55'}, {'value': '25.5', 'groupId': 'OG003', 'lowerLimit': '18', 'upperLimit': '35.4'}]}]}, {'title': 'CD4+FOXP3-CD45RA-CTLA4+OX40+', 'categories': [{'measurements': [{'value': '0.508', 'groupId': 'OG000', 'lowerLimit': '0.2425', 'upperLimit': '50.0535'}, {'value': '0.242', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '0.434'}, {'value': '0.2645', 'groupId': 'OG002', 'lowerLimit': '0.0736', 'upperLimit': '0.619'}, {'value': '0.6175', 'groupId': 'OG003', 'lowerLimit': '0.31', 'upperLimit': '1.37'}]}]}, {'title': 'CD4+FOXP3-CD45RA-CTLA4+OX40-', 'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '0.9599', 'upperLimit': '2.865'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.52', 'upperLimit': '2.54'}, {'value': '2.39', 'groupId': 'OG002', 'lowerLimit': '1.79', 'upperLimit': '3.34'}, {'value': '1.845', 'groupId': 'OG003', 'lowerLimit': '1.36', 'upperLimit': '3.58'}]}]}, {'title': 'CD4+FOXP3-CD45RA-CTLA4-OX40+', 'categories': [{'measurements': [{'value': '3.035', 'groupId': 'OG000', 'lowerLimit': '1.2051', 'upperLimit': '4.495'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '0.763', 'upperLimit': '4.36'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '0.603', 'upperLimit': '5.855'}, {'value': '4.015', 'groupId': 'OG003', 'lowerLimit': '1.71', 'upperLimit': '11.3'}]}]}, {'title': 'CD4+FOXP3-CD45RA-CTLA4-OX40-', 'categories': [{'measurements': [{'value': '41.25', 'groupId': 'OG000', 'lowerLimit': '19.5529', 'upperLimit': '49.1'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '58.4'}, {'value': '53.05', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '66.8'}, {'value': '56.05', 'groupId': 'OG003', 'lowerLimit': '51.4', 'upperLimit': '68.2'}]}]}, {'title': 'CD4+FOXP3-CTLA4+', 'categories': [{'measurements': [{'value': '3.825', 'groupId': 'OG000', 'lowerLimit': '2.92', 'upperLimit': '52.015'}, {'value': '2.34', 'groupId': 'OG001', 'lowerLimit': '2.13', 'upperLimit': '3.62'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.14', 'upperLimit': '4.52'}, {'value': '3.55', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '6.47'}]}]}, {'title': 'CD4+FOXP3-OX40+', 'categories': [{'measurements': [{'value': '5.235', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '53.095'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '1.34', 'upperLimit': '5.2'}, {'value': '2.27', 'groupId': 'OG002', 'lowerLimit': '0.858', 'upperLimit': '7.995'}, {'value': '5.675', 'groupId': 'OG003', 'lowerLimit': '2.65', 'upperLimit': '13.1'}]}]}, {'title': 'CD4+polypositives FOXP3-CD45RA+CTLA4+OX40', 'categories': [{'measurements': [{'value': '0.0488', 'groupId': 'OG000', 'lowerLimit': '0.0392', 'upperLimit': '0.2813'}, {'value': '0.0366', 'groupId': 'OG001', 'lowerLimit': '0.0252', 'upperLimit': '0.0662'}, {'value': '0.0359', 'groupId': 'OG002', 'lowerLimit': '0.0195', 'upperLimit': '0.0803'}, {'value': '0.0646', 'groupId': 'OG003', 'lowerLimit': '0.0349', 'upperLimit': '0.126'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'HBc CD4+FOXP3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.36'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.53'}, {'value': '0.42', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '0.67'}, {'value': '0.52', 'groupId': 'OG003', 'lowerLimit': '0.12', 'upperLimit': '0.81'}]}]}, {'title': 'HBc CD4+FOXP3+CD69+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '1.08'}, {'value': '0.84', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '2.8'}, {'value': '1.0115', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '1.56'}]}]}, {'title': 'HBc CD4+FOXP3+LAP+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.08'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.087'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.296'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.158'}]}]}, {'title': 'HBc CD4+FOXP3+CD69+LAP+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.072'}, {'value': '0.082', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.32'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.128'}]}]}, {'title': 'HBc CD4+FOXP3+CD69+LAP-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.55'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '1.14'}, {'value': '1.09', 'groupId': 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[{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'CD4+FOXP3+CD69+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.2301'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.62'}, {'value': '0.8', 'groupId': 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'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0351'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.67'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '2.2'}]}]}, {'title': 'CD4+FOXP3+CD69-LAP+', 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '0.74'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.055', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.25'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.274'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 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'0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD4+CD40L-IL2-IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0068'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD4+CD40L-IL2-IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0015'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD4+CD40L-IL2+IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0036'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.004'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD4+CD40L-IL2+IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0044'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0143'}, {'value': '0.0017', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0108'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0035'}]}]}, {'title': 'HBs CD4+CD40L-IL2-IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 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on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of 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'0.0101'}]}]}, {'title': 'HBc CD8+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0153'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0345'}, {'value': '0.0021', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0523'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0097'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0005'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0016'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0017'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0016'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0039', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.007'}, {'value': '0.0052', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0106'}, {'value': '0.0002', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0126'}, {'value': '0.0066', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0111'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0005'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0034'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0014'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0034', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0155'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0251', 'groupId': 'OG000', 'lowerLimit': '0.0115', 'upperLimit': '0.0548'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0097'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0048'}, {'value': '0.0008', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0113'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.001'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0035'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0041'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0025'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.004'}, {'value': '0.0021', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.045'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0044'}]}]}, {'title': 'HBs CD8+CD40L+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0046', 'groupId': 'OG000', 'lowerLimit': '0.0005', 'upperLimit': '0.009'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0057'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0118'}, {'value': '0.0002', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0073'}]}]}, {'title': 'HBs CD8+IFNg+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0167', 'groupId': 'OG000', 'lowerLimit': '0.0087', 'upperLimit': '0.0324'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0064'}, {'value': '0.0027', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0155'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0117'}]}]}, {'title': 'HBs CD8+IL2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.011'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.031'}, {'value': '0.0013', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0066'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0049'}]}]}, {'title': 'HBs CD8+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0158'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0448'}, {'value': '0.0015', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0462'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0395'}]}]}, {'title': 'HBs CD8+CD40L+IL2+IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0026'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2+IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2-IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2-IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0019'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2+IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2+IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0017', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0074'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0003'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2-IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L+IL2-IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0046', 'groupId': 'OG000', 'lowerLimit': '0.0005', 'upperLimit': '0.0083'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0083'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0106'}, {'value': '0.0002', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0038'}]}]}, {'title': 'HBs CD8+CD40L-IL2+IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0139'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L-IL2+IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L-IL2-IFNg+IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0016', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0035'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0038'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L-IL2-IFNg+IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0126', 'groupId': 'OG000', 'lowerLimit': '0.0056', 'upperLimit': '0.0198'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0067'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0126'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0348'}]}]}, {'title': 'HBs CD8+CD40L-IL2+IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0019'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0019'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0009'}]}]}, {'title': 'HBs CD8+CD40L-IL2+IFNg-IL17-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0041'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0066'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBs CD8+CD40L-IL2-IFNg-IL17+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.029'}, {'value': '0.0026', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0446'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0269'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD8, CD40-L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'HBc CD4+CD40L+', 'categories': [{'measurements': [{'value': '0.0048', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0095'}, {'value': '0.108', 'groupId': 'OG001', 'lowerLimit': '0.0148', 'upperLimit': '0.337'}, {'value': '0.0336', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.2448'}, {'value': '0.032', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.453'}]}]}, {'title': 'HBc CD4+IFNg+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0099'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0097'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+IL2+', 'categories': [{'measurements': [{'value': '0.0161', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0321'}, {'value': '0.0128', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0486'}, {'value': '0.0033', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0245'}, {'value': '0.0083', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0368'}]}]}, {'title': 'HBc CD4+IL17+', 'categories': [{'measurements': [{'value': '0.0063', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0124'}, {'value': '0.0012', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0046'}, {'value': '0.0047', 'groupId': 'OG002', 'lowerLimit': '0.0002', 'upperLimit': '0.0154'}, {'value': '0.0037', 'groupId': 'OG003', 'lowerLimit': '0.0007', 'upperLimit': '0.0139'}]}]}, {'title': 'HBc CD4+CD40L+IL2+IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2+IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2-IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2-IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0014'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0007'}]}]}, {'title': 'HBc CD4+CD40L+IL2+IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2+IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0009'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2-IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L+IL2-IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0048', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0095'}, {'value': '0.105', 'groupId': 'OG001', 'lowerLimit': '0.0148', 'upperLimit': '0.347'}, {'value': '0.031', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.2438'}, {'value': '0.031', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.45'}]}]}, {'title': 'HBc CD4+CD40L-IL2+IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L-IL2+IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0008'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L-IL2-IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L-IL2-IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0085'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0095'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L-IL2+IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD4+CD40L-IL2+IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0161', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0321'}, {'value': '0.0104', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0522'}, {'value': '0.0022', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0213'}, {'value': '0.0083', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0348'}]}]}, {'title': 'HBc CD4+CD40L-IL2-IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0063', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0124'}, {'value': '0.0012', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0057'}, {'value': '0.0048', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0158'}, {'value': '0.0039', 'groupId': 'OG003', 'lowerLimit': '0.0007', 'upperLimit': '0.0139'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'OG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'OG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'classes': [{'title': 'HBc CD8+CD40L+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0556', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.1472'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0265'}, {'value': '0.0035', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0193'}]}]}, {'title': 'HBc CD8+IFNg+', 'categories': [{'measurements': [{'value': '0.0246', 'groupId': 'OG000', 'lowerLimit': '0.0127', 'upperLimit': '0.0365'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0239'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0248'}, {'value': '0.0002', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.023'}]}]}, {'title': 'HBc CD8+IL2+', 'categories': [{'measurements': [{'value': '0.0448', 'groupId': 'OG000', 'lowerLimit': '0.0078', 'upperLimit': '0.0819'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0195'}, {'value': '0.0004', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.015'}, {'value': '0.0042', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0105'}]}]}, {'title': 'HBc CD8+IL17+', 'categories': [{'measurements': [{'value': '0.1191', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.238'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0768'}, {'value': '0.0058', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0716'}, {'value': '0.0075', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.15'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2+IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L+IL2-IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0556', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.1554'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0277'}, {'value': '0.0035', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0193'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0011'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0012'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg+IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg+IL17-', 'categories': [{'measurements': [{'value': '0.0246', 'groupId': 'OG000', 'lowerLimit': '0.0127', 'upperLimit': '0.0365'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0227'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0217'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.023'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.0001', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}, {'value': '0.0001', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0001'}]}]}, {'title': 'HBc CD8+CD40L-IL2+IFNg-IL17-', 'categories': [{'measurements': [{'value': '0.0448', 'groupId': 'OG000', 'lowerLimit': '0.0078', 'upperLimit': '0.0819'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0109'}, {'value': '0.0053', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0153'}, {'value': '0.0002', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.0088'}]}]}, {'title': 'HBc CD8+CD40L-IL2-IFNg-IL17+', 'categories': [{'measurements': [{'value': '0.1166', 'groupId': 'OG000', 'lowerLimit': '0.0001', 'upperLimit': '0.233'}, {'value': '0.0001', 'groupId': 'OG001', 'lowerLimit': '0.0001', 'upperLimit': '0.0768'}, {'value': '0.0058', 'groupId': 'OG002', 'lowerLimit': '0.0001', 'upperLimit': '0.0761'}, {'value': '0.0075', 'groupId': 'OG003', 'lowerLimit': '0.0001', 'upperLimit': '0.152'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD8, CD40L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).', 'unitOfMeasure': 'Treg cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'FG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'FG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'FG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study period (i.e., from study initiation until study completion) was approximately 22 months (i.e., from April-2010 until February-2012). The duration of the study was one day for each subject.', 'preAssignmentDetails': 'All 99 subjects enrolled in the study were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Immune Tolerant Patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.'}, {'id': 'BG001', 'title': 'HBeAg Positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.'}, {'id': 'BG002', 'title': 'Inactive Carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.'}, {'id': 'BG003', 'title': 'HBeAg Negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '39.7', 'spread': '15.1', 'groupId': 'BG003'}, {'value': '36.43', 'spread': '11.19', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic Ancestry', 'categories': [{'title': 'African heritage/African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'Asian-Central/South Asian heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian-East Asian heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White-Arabic/North African heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'White-Caucasian/European heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Other: Kazakstan', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Other: Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2010-04-01', 'resultsFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2010-04-01', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-24', 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.'}, {'measure': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.'}, {'measure': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.'}, {'measure': 'Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.'}, {'measure': 'Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.'}, {'measure': 'Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.'}, {'measure': 'Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.'}], 'secondaryOutcomes': [{'measure': 'Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).'}, {'measure': 'Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD8, CD40-L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).'}, {'measure': 'Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).'}, {'measure': 'Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples', 'timeFrame': 'At the time of the visit for each subject (i.e., Day 0)', 'description': 'The frequency was assessed based on the following range of markers: CD8, CD40L, IFNg, IL-2 and IL-17.\n\nNote: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunological assays', 'Chronic hepatitis B'], 'conditions': ['Immunologic Tests']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and characterize immunological assays on blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained from the subject.\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.\n* A male or female between, and including, 18 and 65 years of age at study start.\n* Evidence of chronic hepatitis B infection as per medical record.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 day prior to study start.\n\nIn addition to these general inclusion criteria, subjects should satisfy ALL specific criteria according to the specified group maximum 6 months prior to Visit 1 as per medical records:\n\nGroup A: Immune tolerant patients\n\n* Viral load: \\> 2x107 IU/mL of HBV DNA\n* HBeAg positive\n* Normal levels of ALT according to lab range Group B: HBeAg positive chronic hepatitis B patients\n* Viral load: \\> 2x104 IU/mL of HBV DNA\n* HBeAg positive\n* Increased levels of ALT and/or evidence of chronic hepatitis on liver biopsy Group C: Healthy carriers\n* Viral load: not exceeding 2x103 IU/mL of HBV DNA\n* HBeAg negative\n* Normal levels of ALT measured at least twice, at least 3 months apart, during the last 6 months Group D: HBeAg negative chronic hepatitis B patients\n* Viral load: \\> 2x103 IU/mL of HBV DNA\n* HBeAg negative\n* Increased levels of ALT and/or evidence of chronic hepatitis on liver biopsy\n\nExclusion Criteria:\n\n* Any hepatitis B specific treatment prior to blood sampling at Visit 1.\n* Any known clinically significant anaemia or any other condition within 7 days prior to study entry (Visit 1) as per medical records that would preclude the drawing of blood as described in the protocol.\n* Receipt of live attenuated vaccines within 30 days preceding the blood sampling at Visit 1 and the administration of a pandemic influenza vaccine within 21 days preceding the blood sampling at Visit 1.\n* Receipt of blood products within 120 days prior to study entry (Visit 1).\n* Receipt of immunoglobulins within 120 days prior to study entry (Visit 1).\n* Receipt of interferon within 120 days prior to study entry (Visit 1).\n* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding study start, or planned use during the study period.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* History of immunosuppressive or immune-mediated disorders including autoimmune diseases, human immunodeficiency virus (HIV) infection and hepatitis C infection, based on medical history and physical examination (no laboratory testing required).\n* Pregnant or lactating female.\n* History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs (including chloroquine) within six months prior to the blood sampling at Visit 1 (for corticosteroids, this will mean prednisone ≥10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids are allowed.\n* History of type I or type II diabetes mellitus including cases controlled with diet alone (a subject with past gestational diabetes is eligible).\n* History of major congenital defect.\n* Subjects with a history of, or current, alcohol or substance abuse.'}, 'identificationModule': {'nctId': 'NCT01098006', 'briefTitle': 'A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays', 'orgStudyIdInfo': {'id': '113854'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immune tolerant patients Group', 'description': 'Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B viruss (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.', 'interventionNames': ['Other: Blood withdrawal']}, {'type': 'OTHER', 'label': 'HBeAg positive Group', 'description': 'HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with activee inflammation and varying degrees of liver fibbrosis.', 'interventionNames': ['Other: Blood withdrawal']}, {'type': 'OTHER', 'label': 'Inactive carriers Group', 'description': 'Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.', 'interventionNames': ['Other: Blood withdrawal']}, {'type': 'OTHER', 'label': 'HBeAg negative Group', 'description': 'HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.', 'interventionNames': ['Other: Blood withdrawal']}], 'interventions': [{'name': 'Blood withdrawal', 'type': 'OTHER', 'description': 'A single blood sample was to be taken from all subjects at the study visit. No study-related treatment was given to the study participants.', 'armGroupLabels': ['HBeAg negative Group', 'HBeAg positive Group', 'Immune tolerant patients Group', 'Inactive carriers Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}