Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT03676634
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001906', 'term': 'Botulism'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D005517', 'term': 'Foodborne Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Stephen.Arnon@cdph.ca.gov', 'phone': '510-231-7600', 'title': 'Stephen S. Arnon, M.D., M.P.H., Chief, Infant Botulism Treatment and Prevention Program', 'organization': 'California Department of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.', 'description': 'Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.', 'eventGroups': [{'id': 'EG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 5, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'injection site erythema', 'notes': 'general disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'injection site induration', 'notes': 'general disorders and administration site disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'injection site pain', 'notes': 'general disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'seriousEvents': [{'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.'}], 'classes': [{'title': 'Proportion of participants with a ≥4x increase in type A NAC', 'categories': [{'measurements': [{'value': '.844', 'groupId': 'OG000', 'lowerLimit': '.672', 'upperLimit': '.947'}]}]}, {'title': 'Proportion of participants with a ≥3x increase in type A NAC', 'categories': [{'measurements': [{'value': '.938', 'groupId': 'OG000', 'lowerLimit': '.792', 'upperLimit': '.992'}]}]}, {'title': 'Proportion of participants with a ≥4x increase in type B NAC', 'categories': [{'measurements': [{'value': '.875', 'groupId': 'OG000', 'lowerLimit': '.710', 'upperLimit': '.965'}]}]}, {'title': 'Proportion of participants with a ≥3x increase in type B NAC', 'categories': [{'measurements': [{'value': '.906', 'groupId': 'OG000', 'lowerLimit': '.750', 'upperLimit': '.980'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'single proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.844', 'ciLowerLimit': '.672', 'ciUpperLimit': '.947', 'estimateComment': 'Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965', 'groupDescription': 'Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 4', 'description': 'Neutralizing Antibody Concentration in Plasma', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Population: All participants who received rBV A/B, had a baseline NAC, and had at least one post-vaccination immunogenicity assessment up to and including four weeks after administration of rBV A/B'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.'}], 'classes': [{'title': 'two times or greater increase in type A NAC compared with Week 0', 'categories': [{'measurements': [{'value': '.906', 'groupId': 'OG000', 'lowerLimit': '.750', 'upperLimit': '.980'}]}]}, {'title': 'two times or greater increase in type B NAC compared with Week 0', 'categories': [{'measurements': [{'value': '.844', 'groupId': 'OG000', 'lowerLimit': '.672', 'upperLimit': '.947'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to 12', 'description': 'Neutralizing Antibody Concentration in Plasma', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Population: All participants who received rBV A/B, had a baseline NAC, and had at least one post-vaccination immunogenicity assessment up to and including four weeks after administration of rBV A/B'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.'}], 'classes': [{'title': 'Total volume of plasma from all donating participants', 'categories': [{'measurements': [{'value': '470,102', 'groupId': 'OG000'}]}]}, {'title': 'Total volume of plasma from donating participants with any positive titer', 'categories': [{'measurements': [{'value': '470,102', 'groupId': 'OG000'}]}]}, {'title': 'Total volume of plasma from donating participants with positive anti-A titer', 'categories': [{'measurements': [{'value': '470,102', 'groupId': 'OG000'}]}]}, {'title': 'Total volume of plasma from donating participants with positive anti-B titer', 'categories': [{'measurements': [{'value': '469,411', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to 4', 'description': 'Neutralizing Antibody Concentration in Plasma', 'unitOfMeasure': 'mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma-Donating Population: all participants who received rBV A/B and donated at least one plasma unit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Screening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Participants Received rBV A/B Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Participants Included in the Plasma-donating Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Participants Completed Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Red blood cell loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Out-of-limit pulse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 32 participants were enrolled during the recruiting period from 07 March 2019 to 29 August 2019.', 'preAssignmentDetails': 'All enrolled participants participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '0.5 mL rBV A/B', 'description': 'A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '8.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous BabyBIG Plasma Donor', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-05', 'size': 855755, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-10T09:48', 'hasProtocol': True}, {'date': '2019-02-20', 'size': 440437, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-10T09:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2018-09-17', 'resultsFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-22', 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer', 'timeFrame': 'Week 0 to 4', 'description': 'Neutralizing Antibody Concentration in Plasma'}], 'primaryOutcomes': [{'measure': 'Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)', 'timeFrame': 'Week 0 to Week 4', 'description': 'Neutralizing Antibody Concentration in Plasma'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)', 'timeFrame': 'Week 0 to 12', 'description': 'Neutralizing Antibody Concentration in Plasma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Botulism']}, 'descriptionModule': {'briefSummary': 'This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have received pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection under BB IND 0161 (or BB-IND-0161 and IND 015155)\n2. Be 18 to 69 years old at the time of consent\n3. Be healthy and have an acceptable medical history that will not interfere with the objectives of the study\n4. Meet the participant suitability requirements and recommendations for source plasma donors outlined in Appendix A.\n5. If female, and of childbearing potential, have a negative pregnancy test at screening and within 24 hours prior to vaccination and must not plan to become pregnant until after the last plasma donation or until the Week 12 visit (\\[whichever occurs last\\].\n6. Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by the Committee for the Protection of Human Subjects, and have agreed to abide by the study restrictions and to return for the required assessments\n7. Agree to complete the participant home diary on a daily basis for 7 days post vaccination, as well as to report any adverse events and concomitant medications during the study period\n8. Have provided written authorization for use and disclosure of protected health information\n9. Agree not to donate blood or blood products (outside of study procedures) until after the last plasma donation or until the Week 12 visit (whichever occurs last)\n10. Have personal health insurance\n\nExclusion Criteria:\n\n1. Be pregnant or nursing\n2. Have a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses (HIV) 1 or 2, human T-cell lymphotropic virus 1, hepatitis B virus (HBV), or hepatitis C virus (HCV)\n3. Have had a prior severe (Grade 3 or higher) local or severe (Grade 3 or higher) systemic reaction to last immunization with pentavalent botulinum toxoid or a prior severe immediate hypersensitivity reaction or severe systemic reaction to last vaccination on Day 0 with rBV A/B\n4. Have known allergy to aluminum, yeast, or other components of the vaccine\n5. Have donated one or more units of blood or undergone plasmapheresis within 49 days of the Vaccination Visit (Day 0)\n6. Have received blood product or immunoglobulin within 6 months prior to study entry or plans to receive such products during the study period (exclusive of returned red blood cells as part of the plasmapheresis procedure). For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)\n7. Have received licensed nonliving vaccine within 14 days prior to study entry, or licensed live vaccine within 60 days prior to study entry\n8. Have received investigational products (drugs, biologics, vaccines, or implantable devices) 60 days prior to study entry or plans to receive experimental products at any time during the study period. For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)\n9. Have received prescription immunosuppressive or immunomodulatory agents, including parenteral, inhaled, or oral corticosteroids within 3 months of study entry or plans on receiving such therapy at any time during the study period \\[For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)\\], with the exceptions mentioned below\n\n * Participants who have used prescription topical steroids may be enrolled 2 weeks after the therapy is completed\n * Intra-articular, bursal, or tendon injectable steroids are permitted\n * Any over-the-counter topical steroid use is permitted\n * Ophthalmic and intranasal steroids are permitted\n10. Have received cytotoxic therapy at any time in the previous 5 years before study entry\n11. Have an active systemic or recurrent disease that would place the participant at unacceptable risk of injury, require hospitalization, or require surgical intervention (This includes active mental illness or history of mental illness not responsive to treatment.)\n12. Have a history of alcohol or drug abuse or dependence within 12 months of study entry\n13. Have past, present, or suspected illicit injection drug use\n14. Have inflammatory, vasculitic, or rheumatic disease, including systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis, or scleroderma (Stable osteoarthritis treated with physical therapy and nonsteroidal anti inflammatory drugs is not an exclusion criterion.)\n15. Have any acute or chronic neuromuscular or neurologic disorder\n16. Have clinically confirmed hepatic or renal insufficiency\n17. Have uncontrolled hypertension, as defined a systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 90 mmHg\n18. Have moderate to severe asthma, chronic obstructive pulmonary disease, or other significant pulmonary disease\n19. Have a seizure disorder\n20. Have moderate or severe illness or oral temperature of 100.4°F or greater within 3 days of Vaccination Visit (Day 0)\n21. Be unsuitable for participation in this study for any reason, as assessed by the investigator'}, 'identificationModule': {'nctId': 'NCT03676634', 'briefTitle': 'Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®', 'organization': {'class': 'OTHER', 'fullName': 'California Department of Public Health'}, 'officialTitle': 'Tolerability and Immunogenicity of a Single 40-µg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG® in Volunteers With Existing Botulinum Immunity', 'orgStudyIdInfo': {'id': 'rBV A/B-CL-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine', 'description': 'rBV A/B', 'interventionNames': ['Biological: rBV A/B']}], 'interventions': [{'name': 'rBV A/B', 'type': 'BIOLOGICAL', 'description': 'Recombinant Botulinum Vaccine A/B, rBV A/B', 'armGroupLabels': ['Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94804', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'California Department of Public Health', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '43162', 'city': 'West Jefferson', 'state': 'Ohio', 'country': 'United States', 'facility': 'Battelle Biomedical Research Center', 'geoPoint': {'lat': 39.94478, 'lon': -83.2688}}], 'overallOfficials': [{'name': 'Stephen Arnon, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Department of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Department of Public Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}