A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus (RVF)

NCT03609398 Phase 2 RECRUITING

This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 2
Status	RECRUITING
Enrolment	500
Start date	2018-10-04
Completion	2024-12

Conditions

• Rift Valley Fever

Interventions

• RVF Vaccine

Primary outcomes

• Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine — 0-28 days after each dose
  Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
• Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects — 21-35 days after each vaccination and month 12
  Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.

Countries

United States