Venezuelan Equine Encephalomyelitis Clinical Trial
Official title:
Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, as Booster Vaccination in Adult Subjects at Risk of Exposure to VEE Virus
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.
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. ;
| 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 |