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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
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
Special Immunizations Program/USAMRIID
Fort Deterick, Maryland, United States
Percentage of Subjects Who Develop titers of >1:20
The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Time frame: Month 12-15
GMT for PRNT80 Titers of Subjects at Each Scheduled Time Point
The geometric mean PRNT80 titers of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Time frame: Month 12-15
Percentage of Subjects with Adverse Events (AEs) Following Vaccination
Safety will be evaluated by the nature (body system affected), type \[local or systemic\], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Time frame: Month 12-15
Percentage of Subjects with Each AE Type (local or systemic)
Safety will be evaluated by the nature (body system affected), type \[local or systemic\], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Time frame: Month 12-15
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