Western Equine Encephalitis Vaccine (WEE)
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
|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|
- Safety [ Time Frame: Through 28 days post vaccination ] [ Designated as safety issue: No ]Safety will be assessed from signing of consent document through study completion or withdrawal. Subjects will be assessed for AE's through 28 days after each vaccination. AE's reported by a subject or observed byt the PI will be reocrded individually on the AE sheet and then entered into the electronic AE CRF.
- 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:||April 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Biological: Western Equine Encephalitis Vaccine
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.
|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|