This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: August 2011
Study Objectives: 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.
- Biological: 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.
Arms, Groups and Cohorts
- Experimental: 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)
Clinical Trial Outcome Measures
- Subjects Reporting Adverse Events by Vaccination and Sex
- Time Frame: 28 days following each vaccination
- Time Frame: Baseline and multiple dates throughout study
- 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. The secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- U.S. Army Medical Research and Development Command
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ronald B Reisler, MD, Principal Investigator, USAMRIID Medical Division
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