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Safety and Immunogenicity of Live-Attenuated MP-12 Rift Valley Fever Vaccine in Humans, and Genetic Characterization of Virus Isolates Recovered From the Blood of Vaccinated Volunteers: A Phase II Study
This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune response (which fights off infection) and if the vaccine is stable or if the virus used to make the vaccine changes into a different form once injected into the body. Twenty healthy volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12, injected into a muscle.
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2006-08 |
| Completion | 2009-05 |
Conditions
- Rift Valley Fever
Interventions
- RVF MP-12
Primary outcomes
- Safety as Measured by the Number of Adverse Events — up to 1 year
AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.
Countries
United States