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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: 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

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

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

Current Primary Outcome:

  • PRNT80 ≥ 1:40 after primary series [ Time Frame: Between Days 28-42 ]
    % vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
  • PRNT80 ≥ 1:40 after 6-month mandatory booster dose [ Time Frame: 7 months ]
    % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
  • (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 [ Time Frame: up to 5 years ]
    % initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
  • Median duration of PRNT80 ≥ 1:40 in initial responders [ Time Frame: up to 5 years ]
    Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
  • Median duration of PRNT80 ≥ 1:40 in initial non-responders [ Time Frame: up to 5 years ]
    Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
  • Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 [ Time Frame: up to 1 year ]
    Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.


Original Primary Outcome: Safety: The nature and frequency of adverse events for the assessment population, on a per dose basis. Immunogenicity: 80% plaque reduction nuetralization assay (PRNT80). [ Time Frame: AEs: recorded through day 28 after each dose; SAEs: duration of study; Immunogenicity: PRNT80 at 21-35 days after each primary or booster dose, and annually. ]

Current Secondary Outcome:

  • Subjects without symptoms [ Time Frame: 5 years ]
  • Subjects with any category of local reaction (grade 1-4). [ Time Frame: 5 years ]
  • Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). [ Time Frame: 5 years ]
  • Subjects with generalized allergic reactions [ Time Frame: 5 years ]


Original Secondary Outcome: Secondary Immunogenicity: Documented occurrence of Rift Valley fever following exposure to RVF virus in a vaccinated individual. [ Time Frame: Entire length of study ]

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

Dates:
Date Received: March 25, 2009
Date Started: June 2009
Date Completion: June 2018
Last Updated: November 9, 2016
Last Verified: August 2016