Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00582504
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2007-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-05', 'releaseDate': '2023-06-15'}], 'estimatedResultsFirstSubmitDate': '2023-06-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004685', 'term': 'Encephalomyelitis, Venezuelan Equine'}], 'ancestors': [{'id': 'D004683', 'term': 'Encephalomyelitis, Equine'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)', 'timeFrame': '21-35 days, 42-56 days, 12-15 months'}, {'measure': 'Number of adverse events.', 'timeFrame': '7 years'}], 'secondaryOutcomes': [{'measure': 'Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Encephalitis,VEE'], 'conditions': ['Venezuelan Equine Encephalomyelitis']}, 'descriptionModule': {'briefSummary': 'This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* VEE PRNT80 \\< 1:10 before immunization.\n* (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.\n* Actively enrolled in the SIP\n* At risk for exposure to virulent VEE virus (with up-to-date risk assessment).\n* Up-to-date (within 1 year) physical examination/tests.\n* Sign and date the approved informed consent.\n* Willing to return for all follow-up visits.\n* Agree to report adverse event (AE) up to 28 days after vaccination.\n\nExclusion Criteria:\n\n* Over age of 65 years.\n* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.\n* History of immunodeficiency or current treatment with immunosuppressive medication.\n* (females) Currently breastfeeding.\n* Confirmed human immunodeficiency virus (HIV) titer.\n* Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (\\> 125 mg/dL).\n* Serious allergic reaction to guinea pigs/guinea pig products.\n* Any known allergies to components of the vaccine.\n* A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).\n* Administration of any vaccine within 28 days of TC-83.\n* Any unresolved AEs resulting from a previous immunization.'}, 'identificationModule': {'nctId': 'NCT00582504', 'acronym': 'VEE TC-83', 'briefTitle': 'Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus', 'orgStudyIdInfo': {'id': 'A-14317'}, 'secondaryIdInfos': [{'id': 'FY06-26', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccination', 'description': 'VEE TC-83', 'interventionNames': ['Biological: VEE TC-83']}], 'interventions': [{'name': 'VEE TC-83', 'type': 'BIOLOGICAL', 'description': 'Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm', 'armGroupLabels': ['Vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21702', 'city': 'Fort Deterick', 'state': 'Maryland', 'country': 'United States', 'facility': 'U.S. Army Medical Research Institute of Infectious Diseases', 'geoPoint': {'lat': 39.43538, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'Ronald Reisler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USAMRIID Medical Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-15', 'type': 'RELEASE'}, {'date': '2023-07-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Repurposed Therapeutics, Inc.'}}}}