Clinical Trial: Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Open-Label Safety and Immunogenicity Study of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92, in Healthy Adult Subjects

Brief Summary: This study is being conducted to collect safety and immunogenicity data for the WEE vaccine, TSI-GSD 210. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently).

Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome:

  • Number of adverse events [ Time Frame: Up to 5 years ]
  • Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80 [ Time Frame: Up to 5 years ]
    Immunogenicity data will be collected for all subjects and will be evaluated for all per-protocol subjects. The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:40 as determined by PRNT80 after WEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.


Original Primary Outcome: Same as current

Current Secondary Outcome: Geometric mean of PRNT80 titers [ Time Frame: Up to 5 years ]

The geometric mean PRNT80 titers of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.


Original Secondary Outcome: Same as current

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: June 4, 2015
Date Started: June 2016
Date Completion: June 2021
Last Updated: August 18, 2016
Last Verified: August 2016