NCT00584194

Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine

Detailed description

Study Objectives: The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.

Conditions

• Rift Valley Fever

Interventions

Type	Name	Description
BIOLOGICAL	TSI-GSD 200 RVF Vaccine	Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.

Timeline

• Start date: 2004-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-01-02
• Last updated: 2020-01-03
• Results posted: 2017-07-14

Locations

1 site across 1 country: United States