Viewing Study NCT02814708

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Ignite Creation Date: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2026-02-25 @ 7:23 PM
Study NCT ID: NCT02814708
Status: COMPLETED
Last Update Posted: 2022-01-04
First Post: 2016-06-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
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': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martha.eibl@meduniwien.ac.at', 'phone': '+43-1-4081091', 'title': 'Dr. Martha M. Eibl', 'organization': 'Biomedizinische Forschung & Bio-Produkte AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '27 months', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild to moderate AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 39, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 29, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 53, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 39, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 40, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 50, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervos system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 29, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 81, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 30, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 42, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 24, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 25, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 27, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 75, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 30, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 40, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 33, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 23, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 21, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 24, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza-like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 25, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 22, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 21, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants (Percentage) With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG001', 'title': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG002', 'title': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG003', 'title': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG004', 'title': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG005', 'title': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG006', 'title': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months and 18 months follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'any suspected related systemic AE'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Fold Increase of ELISA IgG Against rTSST-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG001', 'title': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG002', 'title': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG003', 'title': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG004', 'title': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG005', 'title': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'OG006', 'title': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months and 18 months follow up', 'description': 'Fold increase of antibody titer against rTSST-1 ELISA from prevaccination titer. Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer. Comparison with placebo comparator recipients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population included in calculation analysed over time by treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG001', 'title': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG002', 'title': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG003', 'title': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG004', 'title': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG005', 'title': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'FG006', 'title': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG001', 'title': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG002', 'title': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG003', 'title': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG004', 'title': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG005', 'title': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG006', 'title': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3\n\nrTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '30.2', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '31.2', 'spread': '12.1', 'groupId': 'BG004'}, {'value': '36.6', 'spread': '11.8', 'groupId': 'BG005'}, {'value': '34.2', 'spread': '12.5', 'groupId': 'BG006'}, {'value': '31.9', 'spread': '11.2', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '49', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '91', 'groupId': 'BG007'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '138', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-20', 'size': 414652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-10T07:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Two different doses of rTSST-1 Variant Vaccine were tested in different administrational schedules. These were: a comparison of 10µg versus 100µg rTSST-1 Variant Vaccine administered one, two, or three times.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2016-06-21', 'resultsFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-10', 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants (Percentage) With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment', 'timeFrame': '12 months and 18 months follow up'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Fold Increase of ELISA IgG Against rTSST-1', 'timeFrame': '12 months and 18 months follow up', 'description': 'Fold increase of antibody titer against rTSST-1 ELISA from prevaccination titer. Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer. Comparison with placebo comparator recipients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sepsis', 'Vaccination'], 'conditions': ['Toxic Shock Syndrome']}, 'referencesModule': {'references': [{'pmid': '27296693', 'type': 'RESULT', 'citation': 'Schwameis M, Roppenser B, Firbas C, Gruener CS, Model N, Stich N, Roetzer A, Buchtele N, Jilma B, Eibl MM. Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial. Lancet Infect Dis. 2016 Sep;16(9):1036-1044. doi: 10.1016/S1473-3099(16)30115-3. Epub 2016 Jun 10.'}, {'pmid': '38274114', 'type': 'DERIVED', 'citation': 'Schoergenhofer C, Gelbenegger G, Hasanacevic D, Schoner L, Steiner MM, Firbas C, Buchtele N, Derhaschnig U, Tanzmann A, Model N, Larcher-Senn J, Drost M, Eibl MM, Roetzer A, Jilma B. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024 Jan 5;67:102404. doi: 10.1016/j.eclinm.2023.102404. eCollection 2024 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible for almost all of menstruation associated and more than 50% of all other cases. There is no specific therapy.\n\nThe aim of this study is to extend the safety and tolerability of two doses of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and persistence of antibodies which produced in response to treatment with the BioMed rTSST-1 Variant Vaccine over a period of 12 months. These antibodies are expected to be important in prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64 years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1. Immunization will be repeated 3 months after the first with the same dose and 6 months after the second immunization in the respective groups.\n\nAntibodies will be determined through monitoring TSST-1 binding antibodies as assessed through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of T cell activation (3H Thymidine incorporation; ≥ 50%).', 'detailedDescription': 'The BioMed rTSST-1 Variant Vaccine has been developed by Biomedizinische ForschungsgmbH as one component of a polyvalent staphylococcal vaccine for the prevention of toxic shock and hyperimmunization of donors for the production of TSST-1 immunoglobulin.\n\nThis is a prospective, randomized, parallel control, phase 2 study of extended safety, local tolerance, immunogenicity, and TSST-1 antibody persistence in healthy adults, who have been vaccinated with one, two or three doses of the BioMed rTSST1 Variant Vaccine compared to adjuvant.\n\nOver a period of 60 days prior to entry into the study, 145 male and female subjects 18 - 64 years in age will be screened for eligibility. Screening criteria will include physical examination, medical history, pregnancy/ adequate contraception in females, HIV Ab, hepatitis C virus antibodies (HCV Ab), hepatitis B antigen (HBs Ag) and TSST-1 Ab. 140 qualified subjects will be entered into the study.\n\nGroup 1 will receive 10 µg of rTSST-1 Variant Vaccine and two administrations of Adjuvant; Group 2 will receive the same dose of Vaccine twice and one dose of Adjuvant; and Group 3 will be injected the 10 µg of the Vaccine three times. Groups 4 to 6 will be given 100 µg of Vaccine following the same schedule. Group 7 will receive Al(OH3) adjuvant three times.\n\nPrior to, and 24 h (+3 h) after each vaccination, the subjects will be examined for vital signs. Blood will be drawn for hematology, clinical chemistry tests, and C-reactive protein. Local reactions and adverse events will be assessed in all post vaccination visits.\n\nThe subjects will be followed up for a period of 3 months (± 2 weeks) or optionally 18 months (± 12 weeks) if they decide to take part in the long-term follow-up, during which they will return to the clinic every three months (± 2 weeks). Tests performed will include vital signs, local reactions, clinical chemistry, C-reactive protein. Adverse events will be recorded.\n\nBinding and neutralizing TSST-1 antibodies will be determined prior to each vaccination and every three months during the treatment and follow-up periods.\n\nEach participant will be in the study for 12 to 14, or optionally 24 months, if they decide to take part in the long-term follow-up.\n\nImmunogenicity is defined by seroconversion from a TSST-1 Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 Ab titer. Neutralization will be defined as a three-fold increase of neutralization titer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males or females aged 18-64 years\n* signed informed consent\n* physical exam: no abnormal findings unless considered irrelevant by the investigator\n* uneventful medical history\n* Females with childbearing potential: adequate contraception\n\nExclusion Criteria:\n\n* females with childbearing potential: pregnancy, lactation or unreliable contraception\n* positive HIV Ab and/or positive HCV Ab and/or positive HBsAG signs and symptoms of autoimmunity\n* TSST-1 Ab titer \\> 1:1000\n* current or recent (\\< 1 month) immunosuppressive therapy with corticosteroids or immunomodulators'}, 'identificationModule': {'nctId': 'NCT02814708', 'briefTitle': 'Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomedizinische Forschungs gmbH'}, 'officialTitle': 'Phase 2 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults', 'orgStudyIdInfo': {'id': 'BioMed 0515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Group 1', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Group 2', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Group 3', 'description': 'rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Group 4', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Group 5', 'description': 'rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Group 6', 'description': 'rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3', 'interventionNames': ['Biological: rTSST-1v']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose Group 7', 'description': 'Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3', 'interventionNames': ['Biological: rTSST-1v']}], 'interventions': [{'name': 'rTSST-1v', 'type': 'BIOLOGICAL', 'description': 'Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \\< 20 to \\> 40 or a 4-fold increase in TSST-1 binding Ab titer .', 'armGroupLabels': ['Dose Group 1', 'Dose Group 2', 'Dose Group 3', 'Dose Group 4', 'Dose Group 5', 'Dose Group 6', 'Dose Group 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna Department of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Martha M Eibl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biomedizinische Forschungsgmbh'}, {'name': 'Bernd Jilma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomedizinische Forschungs gmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}