Western Equine Encephalitis Vaccine (WEE)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- Subjects Reporting Adverse Events by Vaccination and Sex [ Time Frame: 28 days following each vaccination ] [ Designated as safety issue: Yes ]
- Immunogenicity [ Time Frame: Baseline and multiple dates throughout study ] [ Designated as safety issue: No ]
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.
|Study Start Date:||February 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159561
|United States, Maryland|
|Clinical Research Unit, Division of Medicine, USAMRIID|
|Fort Detrick, Maryland, United States, 21702-5011|
|Principal Investigator:||Ronald B Reisler, MD||USAMRIID Medical Division|