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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 at Risk of Exposure to Western Equine Encephalitis Virus
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).
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 500 |
| Start date | 2015-12-15 |
| Completion | 2021-12 |
Conditions
- Western Equine Encephalitis
Interventions
- Western Equine Encephalitis (WEE) Vaccine
Primary outcomes
- Number of adverse events — Up to 5 years
- Percentage of subjects who develop titers of ≥ 1:40 as determined by PRNT80 — 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.
Countries
United States