Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2010-02-28
2012-03-31
Brief Summary
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Detailed Description
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Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Vaccinated
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)
Western Equine Encephalitis Vaccine
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.
Interventions
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Western Equine Encephalitis Vaccine
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.
Eligibility Criteria
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Inclusion Criteria
* In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
* Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
* Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
* WEE, EEE, VEE, and CHIK PRNT80\<1:10
* Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form
* Be willing to comply with all follow-up visits, testing, and AE reporting
Exclusion Criteria
* Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
* Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
* 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
* Hypersensitivity to any vaccine
* Allergic to any vaccine component: Human serum albumin, Neomycin
* Receipt of or anticipates receipt of blood products during the study
* Female: Pregnant or breastfeeding
* Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)
18 Years
55 Years
ALL
Yes
Sponsors
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U.S. Army Medical Research and Development Command
FED
Responsible Party
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Principal Investigators
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Ronald B Reisler, MD
Role: PRINCIPAL_INVESTIGATOR
USAMRIID Medical Division
Locations
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Clinical Research Unit, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States
Countries
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References
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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.
Other Identifiers
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USAMRIID FY09-02
Identifier Type: OTHER
Identifier Source: secondary_id
A-15812
Identifier Type: -
Identifier Source: org_study_id
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