Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Trial Parameters
Brief Summary
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Eligibility Criteria
Inclusion Criteria: * Be 18 to 65 years old at time of consent. * Have RVF plaque reduction neutralization 80% titers (PRNT80) \<1:10 for primary series. * Have RVF PRNT80 (plaque reduction neutralization 80% titer) \<1:40 for booster series. * If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination). * Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine. * Sign and date the approved informed consent document and HIPAA Authorization. * Have in their charts: * medical history (including concomitant medications) within 60 days of planned first administration of vaccine * physical examination and laboratory tests within 1 year * previous chest radiogr