NCT00869713

Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

Detailed description

The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated personnel

Conditions

• Rift Valley Fever

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated, Dried (TSI-GSD 200), RVF Vaccine	All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 \& 14, \& once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer \<1:40. Initial non-responders: Individual who has a PRNT80 titer \<1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 \<1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of \<1:40.

Timeline

• Start date: 2009-09-01
• Primary completion: 2019-02-01
• Completion: 2021-05-01
• First posted: 2009-03-26
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States