U.S. Army Medical Research and Development Command
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. 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). Subjects who respond with a titer of \>1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.
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…
1.0 mL dose given SQ in upper arm
Arctuva estimate
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