Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 7:06 PM
Study NCT ID:
NCT01159561
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2010-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Western Equine Encephalitis Vaccine, Inactivated
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects Reporting Adverse Events by Vaccination and Sex', 'timeFrame': '28 days following each vaccination'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'Baseline and multiple dates throughout study', 'description': 'The primary endpoint used to measure immunogeniciyt of the WEE vaccine, the 80% plaque-reduction neautralization titer (PRNT 80), will be evaluated for subjects in the per protocol population.\n\nThe secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Virus']}, 'referencesModule': {'references': [{'pmid': '33240257', 'type': 'DERIVED', 'citation': 'Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.', 'detailedDescription': 'Study Objectives:\n\nPrimary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.\n\nSecondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-55 years of age\n* In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations\n* Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration\n* Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody\n* WEE, EEE, VEE, and CHIK PRNT80\\<1:10\n* Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form\n* Be willing to comply with all follow-up visits, testing, and AE reporting\n\nExclusion Criteria:\n\n* Participant in the USAMRIID SIP\n* Receipt of any other vaccine or investigational; drug within 30 days prior to study entry\n* Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination\n* Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination\n* Hypersensitivity to any vaccine\n* Allergic to any vaccine component: Human serum albumin, Neomycin\n* Receipt of or anticipates receipt of blood products during the study\n* Female: Pregnant or breastfeeding\n* Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)"}, 'identificationModule': {'nctId': 'NCT01159561', 'acronym': 'WEE', 'briefTitle': 'Western Equine Encephalitis Vaccine, Inactivated', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults', 'orgStudyIdInfo': {'id': 'A-15812'}, 'secondaryIdInfos': [{'id': 'USAMRIID FY09-02', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccinated', 'description': 'Western Equine Encephalitis Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, administered in 0.5 mL doses subcutaneously in the upper outer aspect of the triceps in a 3-dose primary series (Days 0, 7, and 28) with a mandatory boost (Day 180)', 'interventionNames': ['Biological: Western Equine Encephalitis Vaccine']}], 'interventions': [{'name': 'Western Equine Encephalitis Vaccine', 'type': 'BIOLOGICAL', 'description': 'Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.', 'armGroupLabels': ['Vaccinated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21702-5011', 'city': 'Fort Deterick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Research Unit, Division of Medicine, USAMRIID', 'geoPoint': {'lat': 39.43538, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'Ronald B 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'}}}}