Clinical Trial: Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Expo
Brief Summary: This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
Detailed Summary: The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- PRNT80 ≥ 1:40 after primary series [ Time Frame: 3 weeks and 8 weeks ]
- PRNT80 ≥ 1:40 after 6-month booster dose [ Time Frame: 6 months ]
- PRNT80 ≥ 1:40 at 11-13 months after the first primary dose [ Time Frame: 11-13 months ]
- PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses [ Time Frame: Up to 5 years ]
Original Primary Outcome: Safety: The frequency of adverse events in this EEE vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Measurement is the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through day 28 after each dose; SAEs recorded through duration of study; Immunogenicity: PRNT80 will be assessed after primary series and booster dose; Any EEE illness in a vaccinated subject will be recorded for duration of study. ]
Current Secondary Outcome: Number and frequency of local and systemic adverse events [ Time Frame: 5 years ]
Original Secondary Outcome:
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: December 19, 2007
Date Started: February 2008
Date Completion: December 2017
Last Updated: March 28, 2017
Last Verified: March 2017
