Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT00316602
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2006-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D012899', 'term': 'Smallpox'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527606', 'term': 'smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@bavarian-nordic.com', 'phone': '+45 3326', 'title': 'Program Lead, Clinical Operations', 'phoneExt': '8383', 'organization': 'Bavarian Nordic A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '32 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 133, 'seriousNumAtRisk': 282, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)', 'otherNumAtRisk': 350, 'deathsNumAtRisk': 350, 'otherNumAffected': 196, 'seriousNumAtRisk': 350, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Extraocular muscle paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroconversion by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.7'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '98.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroconversion rates (%)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.2', 'ciLowerLimit': '-4.3', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.'}], 'paramType': 'NUMBER', 'timeFrame': 'week 6', 'description': 'Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '18.2'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '28.6'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '90.1'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '89.5'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '99.7'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '98.9'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.7'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '98.8'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '57.7', 'upperLimit': '77.3'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 32 weeks', 'description': 'Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'ELISA GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.7'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.0'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.9'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.4'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '76.4'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '77.4'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '499.4', 'groupId': 'OG000', 'lowerLimit': '417.1', 'upperLimit': '598.0'}, {'value': '532.9', 'groupId': 'OG001', 'lowerLimit': '452.9', 'upperLimit': '627.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '298.0', 'groupId': 'OG000', 'lowerLimit': '252.3', 'upperLimit': '351.8'}, {'value': '314.3', 'groupId': 'OG001', 'lowerLimit': '269.2', 'upperLimit': '366.8'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '32.3'}, {'value': '33.2', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '50.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'within 32 weeks', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.", 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion by PRNT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '9.8'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '9.3'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '31.2'}, {'value': '26.8', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '32.7'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '91.1'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '93.6'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '82.0'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '75.2', 'upperLimit': '85.5'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '32.1'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '30.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 32 weeks', 'description': 'Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'PRNT GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.4'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '1.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.7'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.1'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '3.5'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '45.3'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '59.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '20.6'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '27.9'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '3.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'within 32 weeks', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.", 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'ELISPOT IFN-γ Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '107.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '775'}, {'value': '109.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '871'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '106.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '674'}, {'value': '166.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1800'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '276.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1800'}, {'value': '334.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1800'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within 6 weeks', 'description': 'Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10\\^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay', 'unitOfMeasure': 'Spot Forming Units / 10^6 PBMC', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ELISPOT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Any SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE with intensity >= Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE assessed as related to vaccine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 32 weeks', 'description': 'Occurrence, relationship and intensity of any serious AE (SAE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Related Grade >=3 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 29 days after vaccination', 'description': 'Number of Participants with any Grade \\>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Local Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Pain : Total', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}]}, {'title': 'Pain : Grade >=2', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Pain : Grade >=3', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Erythema : Total', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Erythema : Grade >=2', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Erythema : Grade >=3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Swelling : Total', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Swelling : Grade >=2', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Swelling : Grade >=3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited General AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Body Temperature increased : Total', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Body Temperature increased : Related', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Body Temperature increased : Grade >=3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Body Temperature increased : Related - Grade >=3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Headache : Total', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}]}, {'title': 'Headache : Related', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Headache : Grade >=3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Headache : Related - Grade >=3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia : Total', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia : Related', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia : Grade >=3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia : Related - Grade >=3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Chills : Total', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Chills : Related', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Chills : Grade >=3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Chills : Related - Grade >=3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nausea : Total', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Nausea : Related', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Nausea : Grade >=3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Nausea : Related - Grade >=3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue : Total', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue : Related', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue : Grade >=3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue : Related - Grade >=3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Unsolicited Non-serious Adverse Events: Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 29 days after any vaccination', 'description': 'Occurrence of unsolicited non-serious AEs by Intensity', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'OG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'Unlikely', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Possible', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Probable', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Definite', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 29 days after any vaccination', 'description': 'Occurrence of unsolicited non-serious AEs by relationship to study vaccine', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)\n\nIMVAMUNE: Subjects receiving two subcutaneous vaccinations'}, {'id': 'FG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] \\<= 30), receiving two doses of MVA-BN (IMVAMUNE)\n\nIMVAMUNE: Subjects receiving two subcutaneous vaccinations'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '350'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '325'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject unwilling/unable to comply with', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '350', 'groupId': 'BG001'}, {'value': '632', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)'}, {'id': 'BG001', 'title': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naïve subjects with diagnosed AD. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] ≤ 30)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '5.81', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '6.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}, {'title': 'Oriental/Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 632}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2006-04-20', 'resultsFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2006-04-20', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-19', 'studyFirstPostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Seroconversion by ELISA', 'timeFrame': 'week 6', 'description': 'Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroconversion by ELISA', 'timeFrame': 'within 32 weeks', 'description': 'Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}, {'measure': 'ELISA GMT', 'timeFrame': 'within 32 weeks', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'."}, {'measure': 'Percentage of Participants With Seroconversion by PRNT', 'timeFrame': 'within 32 weeks', 'description': 'Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}, {'measure': 'PRNT GMT', 'timeFrame': 'within 32 weeks', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'."}, {'measure': 'ELISPOT IFN-γ Values', 'timeFrame': 'within 6 weeks', 'description': 'Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10\\^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay'}, {'measure': 'Number of Participants With SAEs', 'timeFrame': 'within 32 weeks', 'description': 'Occurrence, relationship and intensity of any serious AE (SAE)'}, {'measure': 'Number of Participants With Related Grade >=3 Adverse Events', 'timeFrame': 'within 29 days after vaccination', 'description': 'Number of Participants with any Grade \\>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.'}, {'measure': 'Number of Participants With Solicited Local Adverse Events', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.'}, {'measure': 'Number of Participants With Solicited General AEs', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.'}, {'measure': 'Number of Unsolicited Non-serious Adverse Events: Intensity', 'timeFrame': 'within 29 days after any vaccination', 'description': 'Occurrence of unsolicited non-serious AEs by Intensity'}, {'measure': 'Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination', 'timeFrame': 'within 29 days after any vaccination', 'description': 'Occurrence of unsolicited non-serious AEs by relationship to study vaccine'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Smallpox', 'Vaccination'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '26439129', 'type': 'RESULT', 'citation': 'Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis. PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nGroup 1 (Healthy Participants):\n\nSubjects without present or history of any kind of atopy.\n\nGroup 2 (Atopic Dermatitis Participants):\n\nSubjects with diagnosed atopic dermatitis.\n\nAll study subjects:\n\n1. Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.\n2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.\n3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.\n4. Lab values without clinically significant findings.\n5. Electrocardiogram (ECG) without clinically significant findings.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women.\n2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.\n3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.\n4. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.\n5. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.\n6. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.\n7. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.\n8. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.\n9. History of anaphylaxis or severe allergic reaction.\n10. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.\n11. Administration of immunomodulatory substances."}, 'identificationModule': {'nctId': 'NCT00316602', 'briefTitle': 'A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bavarian Nordic'}, 'officialTitle': 'A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'POX-MVA-008'}, 'secondaryIdInfos': [{'id': 'HHSN266200400072C', 'type': 'OTHER_GRANT', 'domain': 'NIAID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Participants', 'description': 'Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)', 'interventionNames': ['Biological: IMVAMUNE']}, {'type': 'EXPERIMENTAL', 'label': 'Atopic Dermatitis Participants', 'description': 'Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \\[SCORAD\\] \\<= 30), receiving two doses of MVA-BN (IMVAMUNE)', 'interventionNames': ['Biological: IMVAMUNE']}], 'interventions': [{'name': 'IMVAMUNE', 'type': 'BIOLOGICAL', 'otherNames': ['MVA-BN'], 'description': 'Subjects receiving two subcutaneous vaccinations', 'armGroupLabels': ['Atopic Dermatitis Participants', 'Healthy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alta Clinical Research LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Rx Clinical Research, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Solano Clinical Research', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Adult & Pediatric Dermatology PC', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40536-0093', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sundance Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87106-5239', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Dermatology Associates of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Dermatology & Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Treatment & Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '07760', 'city': 'Magdalena de las Salinas', 'state': 'CP', 'country': 'Mexico', 'facility': 'Hospital Juárez de México', 'geoPoint': {'lat': 19.4822, 'lon': -99.14672}}, {'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '6760', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital General de México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '45200', 'city': 'Zapopan, Jalisco', 'country': 'Mexico', 'facility': 'Hospital Angel Leañol, Dermatology'}], 'overallOfficials': [{'name': 'Richard N Greenberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bavarian Nordic', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}