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Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.


Clinical Trial Description

Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63. Duration of participation is 12-15 months if the subject demonstrates a PRNT80 of ≥1:20 at 1 year; if not, the vaccination procedure with C-84 will be repeated with a minimum of 28 days between doses. A maximum of four booster doses will be given in a year. If the PRNT80 titer is < 1:20 after four booster doses in any 12-month period, the subject's participation in the study will be placed on hold for 12 months; titers will be repeated at 1 year (± 30 days), and, if required, the subject will be given a booster dose of C-84 vaccine. Safety endpoint measurements will be evaluated for all subjects receiving at least one vaccination under this protocol regardless of compliance with the protocol. Immunogenicity endpoints will be evaluated for subjects who have been vaccinated in compliance with the protocol and who have had blood for titers drawn in compliance with the protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03531242
Study type Interventional
Source U.S. Army Medical Research and Development Command
Contact Anthony P Cardile, DO, MAJ
Phone 301-619-8833
Email anthony.p.cardile.mil@mail.mil
Status Not yet recruiting
Phase Phase 2
Start date June 2021
Completion date December 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00582504 - Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine Phase 2
Active, not recruiting NCT00582088 - Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83 Phase 2