Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 12:54 PM
Study NCT ID:
NCT05506969
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010930', 'term': 'Plague'}, {'id': 'D000079263', 'term': 'Vaccine-Preventable Diseases'}], 'ancestors': [{'id': 'D015009', 'term': 'Yersinia Infections'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ohenry@dynavax.com', 'phone': '617-686-4796', 'title': 'Ouzama Henry, MD', 'organization': 'Dynavax Technologies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).', 'eventGroups': [{'id': 'EG000', 'title': 'rF1V-1018 Co-Administered', 'description': 'rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 18, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'rF1V-1018 Bedside Mix', 'description': 'Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 77, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'rF1V Vaccine Only', 'description': 'rF1V vaccine administered on Days 1, 29, and 183', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 69, 'seriousNumAtRisk': 89, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cor Pulmonale Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complicated Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxicity to Various Agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rates of Reactogenicity and Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rF1V-1018 Co-Administered', 'description': 'rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'OG001', 'title': 'rF1V-1018 Bedside Mix', 'description': 'Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'OG002', 'title': 'rF1V Vaccine Only', 'description': 'rF1V vaccine administered on Days 1, 29, and 183'}], 'classes': [{'title': 'Local Reactions', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Severe Local Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Systemic Reactions', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Severe Systemic Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'At least 1 Unsolicited AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Severe (Grade 3 or 4) AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 56', 'description': 'Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rF1V-1018 Co-Administered', 'description': 'rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'FG001', 'title': 'rF1V-1018 Bedside Mix', 'description': 'Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'FG002', 'title': 'rF1V Vaccine Only', 'description': 'rF1V vaccine administered on Days 1, 29, and 183'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'rF1V-1018 Co-Administered', 'description': 'rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'BG001', 'title': 'rF1V-1018 Bedside Mix', 'description': 'Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183'}, {'id': 'BG002', 'title': 'rF1V Vaccine Only', 'description': 'rF1V vaccine administered on Days 1, 29, and 183'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Mean (SD)', 'categories': [{'measurements': [{'value': '39.1', 'spread': '8.17', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '9.91', 'groupId': 'BG002'}, {'value': '39.0', 'spread': '9.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-39', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': '40+', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '2.46', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '3.04', 'groupId': 'BG001'}, {'value': '25.5', 'spread': '3.16', 'groupId': 'BG002'}, {'value': '25.8', 'spread': '3.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-11', 'size': 3809167, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-18T18:06', 'hasProtocol': True}, {'date': '2024-06-16', 'size': 777319, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-18T18:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-08-10', 'resultsFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-28', 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Reactogenicity and Safety', 'timeFrame': 'Day 1 to Week 56', 'description': 'Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plague, Pneumonic', 'Plague', 'Vaccine-Preventable Diseases']}, 'descriptionModule': {'briefSummary': 'Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age', 'detailedDescription': 'Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant (rF1V-1018) compared with rF1V vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be enrolled to compare a two-dose regimen of rF1V-1018 with a three-dose regimen of rF1V vaccine alone. The study will be conducted in 2 parts (Part 1 and Part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to 55 years\n* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.\n\nPre-existing stable medical condition means a subject who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.\n\n* Able to comply with the protocol schedule and procedures.\n* Able and willing to provide written informed consent\n* If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 28 days prior to vaccination and has negative pregnancy tests just prior to vaccination and has agreed to continue adequate contraception until 28 days after last study injection. Adequate contraception is defined as a contraceptive method with a failure rate of \\< 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:\n\n * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n * Progestin-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n * Intrauterine device (IUD) with or without hormonal release\n * Vasectomized partner, provided he is the subject's sole partner and that he has received a medical assessment of the surgical success\n * Credible self-reported history of heterosexual abstinence for at least 28 days prior to vaccine administration\n * Female partner\n\nExclusion Criteria:\n\n* A history of plague disease or have previously received any plague vaccine.\n* Active tuberculosis or other systemic infectious process.\n* History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV\n* History of autoimmune disorder\n* History of sensitivity to any component of study vaccines\n* Body mass index ≥ 30 kg/m2\n* Has received the following prior to the injection:\n* 14 days:\n* COVID-19 vaccine\n* Any inactivated vaccine\n* 28 days:\n* Any live vaccine\n* Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immunomodulators immune suppressive medication, with the exception of inhaled steroids\n* Any other investigational medicinal agent\n* 90 days:\n* Immunoglobulins or any blood products\n* Granulocyte or granulocyte-macrophage colony-stimulating factor\n* Antisense oligonucleotides\n* Drugs/investigational agents with very long half-lives (defined as ≥ 60 days)\n* At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells\n* If female is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy\n* Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Oral temperature \\>100.0°F at the time of vaccine administration.\n* History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)"}, 'identificationModule': {'nctId': 'NCT05506969', 'briefTitle': 'Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynavax Technologies Corporation'}, 'officialTitle': 'Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age', 'orgStudyIdInfo': {'id': 'DV2-PLG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered)', 'description': 'Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections', 'interventionNames': ['Biological: rF1V-1018']}, {'type': 'EXPERIMENTAL', 'label': 'rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix)', 'description': 'Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections', 'interventionNames': ['Biological: rF1V-1018']}, {'type': 'EXPERIMENTAL', 'label': 'rF1V vaccine only', 'description': 'rF1V vaccine administered as 3 injections', 'interventionNames': ['Biological: rF1V vaccine']}], 'interventions': [{'name': 'rF1V-1018', 'type': 'BIOLOGICAL', 'description': 'rF1V vaccine and CpG 1018® adjuvant', 'armGroupLabels': ['rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered)', 'rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix)']}, {'name': 'rF1V vaccine', 'type': 'BIOLOGICAL', 'description': 'rF1V vaccine', 'armGroupLabels': ['rF1V vaccine only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35802-2569', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Optimal Research Alabama', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Optimal Research California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32934-8172', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Optimal Research Florida', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '61614-4885', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Optimal Research Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Optimal Research Maryland', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '78705-2655', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Optimal Research Texas', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Robert Janssen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dynavax Technologies Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynavax Technologies Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}