Clinical Trial: Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: Safety: Occurrence of AE's/SAEs [ Time Frame: 12 months ]

Collect data on the occurrence of AEs and SAEs


Original Primary Outcome: Safety: The frequency of adverse events in this RVF vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Measurement is the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs: recorded through day 28 after each dose; SAEs: duration of study; Immunogenicity: PRNT80 at 28 days after dose 3. Part B: Pre-6-month dose and 12 month titer. Any RVF illness in a vaccinated subject will be recorded for duration of study. ]

Current Secondary Outcome:

  • Immunogenicity: Geometric mean titers after 3rd vaccination [ Time Frame: 28 days after dose 3 ]
    Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination
  • Immunogenicity: Geometric mean titers before and after 6-month booster [ Time Frame: Before and after 6-month booster ]
    Measurement is the 80% plaque-reduction neutralization titer (PRNT80). Subjects who were non-responders to the primary series and subsequently received boosters
  • Immunogenicity: Geometric mean titers at 12 months [ Time Frame: at 12 months ]
    Measurement is the 80% plaque-reduction neutralization titer (PRNT80). Subjects who were non-responders to the primary series and subsequently received boosters


Original Secondary Outcome:

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: December 20, 2007
Date Started: June 2004
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017