Western Equine Encephalitis Vaccine (WEE)
|ClinicalTrials.gov Identifier: NCT01159561|
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Virus||Biological: Western Equine Encephalitis Vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2010|
|Primary Completion Date :||August 2011|
|Study Completion Date :||March 2012|
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.
- Subjects Reporting Adverse Events by Vaccination and Sex [ Time Frame: 28 days following each vaccination ]
- Immunogenicity [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|