Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-04-21 @ 10:20 AM
Study NCT ID:
NCT03146403
Status:
TERMINATED
Last Update Posted:
2019-02-19
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006558', 'term': 'Herpes Genitalis'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488937', 'term': 'M2 protein, Influenza A virus'}, {'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.lavin@genocea.com', 'phone': '617-876-8191', 'title': 'Jennifer LaVin', 'organization': 'Genocea'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Small numbers of enrolled subjects likely led to a lack of statistical power. After a 2017 business decision to cease GEN-003 spending, the outcome measures were reduced to 6 months of follow up, rather than the originally planned 12 months.'}}, 'adverseEventsModule': {'timeFrame': 'Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.', 'description': 'Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.', 'eventGroups': [{'id': 'EG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 10, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': '≥100.4°F', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Days With Genital Herpes Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '4.23', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.5'}]}]}], 'analyses': [{'pValue': '0.7474', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.'}, {'type': 'SECONDARY', 'title': 'Number of Genital Herpes Recurrences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.6450', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary', 'unitOfMeasure': 'recurrences', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Without Genital Herpes Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'classes': [{'title': 'No Recurrence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'With Recurrence', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3157', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after vaccination', 'description': 'Subject-reported via electronic diary', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.'}, {'type': 'SECONDARY', 'title': 'Days Until First Genital Herpes Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '85.0'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '116.0'}]}]}], 'analyses': [{'pValue': '0.3869', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.'}, {'type': 'SECONDARY', 'title': 'Duration of Genital Herpes Recurrences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '3.40', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.2200', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Time in days per genital herpes recurrence', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection\n\nGEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D\n\nMatrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection\n\n0.9% normal saline: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '50'}, {'value': '40.2', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '52'}, {'value': '40.1', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '52'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.34', 'groupId': 'BG000', 'lowerLimit': '54.0', 'upperLimit': '140.5'}, {'value': '79.20', 'groupId': 'BG001', 'lowerLimit': '53.5', 'upperLimit': '119.3'}, {'value': '80.72', 'groupId': 'BG002', 'lowerLimit': '53.5', 'upperLimit': '140.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-13', 'size': 825425, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-03T10:24', 'hasProtocol': True}, {'date': '2018-02-07', 'size': 1212727, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-03T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': '2017 business decision to cease GEN-003 spending.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2017-05-05', 'resultsFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-29', 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Days With Genital Herpes Lesions', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary'}], 'secondaryOutcomes': [{'measure': 'Number of Genital Herpes Recurrences', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary'}, {'measure': 'Number of Subjects Without Genital Herpes Recurrence', 'timeFrame': '6 months after vaccination', 'description': 'Subject-reported via electronic diary'}, {'measure': 'Days Until First Genital Herpes Recurrence', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Subject-reported via electronic diary'}, {'measure': 'Duration of Genital Herpes Recurrences', 'timeFrame': 'The 6-month period after vaccination', 'description': 'Time in days per genital herpes recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSV', 'Herpes', 'Genital Herpes', 'Vaccine'], 'conditions': ['Genital Herpes', 'HSV-2 Infection']}, 'descriptionModule': {'briefSummary': 'The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.\n\nSubjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.\n\nGEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed Study GEN-003-003\n* Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003\n* Received last dose of GEN-003 within 11 to 18 months prior\n* Reported data in the daily electronic reporting period on at least 80% of days in Study GEN-003-003\n* Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12 swab collection period in Study GEN-003-003\n* Willing and able to provide written informed consent\n* Willing to perform and comply with all study procedures\n* Postmenopausal or willing to practice a highly effective method of contraception for 28 days before and 90 days after enrollment\n\nExclusion Criteria:\n\n* Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect treatment in Study GEN-003-003\n* Use of suppressive antiviral medication within 14 days prior\n* Use of topical steroids or antiviral medication in the anogenital region within 14 days prior\n* Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV recurrence frequency or intensity within 14 days prior\n* History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis\n* Immunocompromised individuals\n* Diagnosis or suspicion of an AESI\n* Diagnosis or suspicion of any other autoimmune disease not listed in Appendix 4 of the protocol\n* Vaccine-related SAE in GEN-003-003\n* Known current infection with HIV or hepatitis B or C virus\n* History of hypersensitivity to any component of the vaccine\n* Prior receipt of another vaccine containing HSV-2 antigens other than GEN-003\n* Receipt of any IP within 30 days prior to the maintenance dose of GEN-003/placebo\n* Receipt of any blood product within 90 days prior to the maintenance dose\n* Receipt of a live vaccine within 28 days prior to or any other vaccine within 14 days prior to maintenance dose\n* Planned use of any vaccine from the maintenance dose to 28 days after the maintenance dose\n* Pregnant or nursing women\n* History of drug or alcohol abuse\n* Other active, uncontrolled comorbidities\n* Changes to medication used to manage an underlying comorbidity within 60 days prior'}, 'identificationModule': {'nctId': 'NCT03146403', 'briefTitle': 'Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genocea Biosciences, Inc.'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection', 'orgStudyIdInfo': {'id': 'GEN-003-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEN-003', 'description': '60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection', 'interventionNames': ['Biological: GEN-003', 'Biological: Matrix-M2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% normal saline administered as a 0.5mL intramuscular (IM) injection', 'interventionNames': ['Other: 0.9% normal saline']}], 'interventions': [{'name': 'GEN-003', 'type': 'BIOLOGICAL', 'otherNames': ['HSV Therapeutic Vaccine'], 'description': 'HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D', 'armGroupLabels': ['GEN-003']}, {'name': 'Matrix-M2', 'type': 'BIOLOGICAL', 'otherNames': ['Adjuvant'], 'description': 'Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.', 'armGroupLabels': ['GEN-003']}, {'name': '0.9% normal saline', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Optimus Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Health', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'NW Dermatology and Research Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Tekton Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genocea Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}