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Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults (RVF)
This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 98 |
| Start date | 2009-09 |
| Completion | 2021-05 |
Conditions
- Rift Valley Fever
Interventions
- Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Primary outcomes
- PRNT80 ≥ 1:40 after primary series — Between Days 28-42
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders). - PRNT80 ≥ 1:40 after 6-month mandatory booster dose — 7 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only). - (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 — up to 5 years
% initial non-responders (PRNT80 \< 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses. - Median duration of PRNT80 ≥ 1:40 in initial responders — up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose. - Median duration of PRNT80 ≥ 1:40 in initial non-responders — up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40. - Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 — up to 1 year
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
Countries
United States