Clinical Trial: Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary
Brief Summary: This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number of participants with a 80% plaque-reduction neutralization titer (PRNT80) [ Time Frame: 21-35 days, 42-56 days, 12-15 months ]
- Number of adverse events. [ Time Frame: 7 years ]
Original Primary Outcome: Safety: Frequency of adverse events for all intent-to-treat subjects with headache, myalgia, fever, malaise, chills, fatigue, sore throat, nausea, and vomiting; Immunogenicity: Response as measured by 80% plaque reduction neutralization titer (PRNT80) [ Time Frame: Safety: AE's:28 days after immunization; SAE's:duration of study; Immunogenicity: PRNT80 at days 28, 56 and 12-15 months after vaccination ]
Current Secondary Outcome: Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20. [ Time Frame: 7 years ]
Original Secondary Outcome: Safety: Frequency of all other adverse events for all intent-to-treat subjects; Immunogenicity: Frequency of VEE disease among vaccinated subjects with documented exposure or with temperature (>100.5 degrees F)after working with VEE virus [ Time Frame: Safety: AE's: 28 days after vaccination; SAE's: duration of study; Immunogenicity: duration of study ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: December 19, 2007
Date Started: September 2007
Date Completion: December 2018
Last Updated: May 2, 2017
Last Verified: May 2017
