NCT03609398

Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Rift Valley Fever

Interventions

Type	Name	Description
BIOLOGICAL	RVF Vaccine	1.0 mL dose given SQ in upper arm

Timeline

• Start date: 2018-10-04
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2018-08-01
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study