The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live, Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of occupational VEE virus infection in vaccinated personnel.
This protocol is replacing NCT00582504. The study population will consist of USAMRIID and qualified extramural participants who are at risk of exposure to VEE virus. This study will be performed at the USAMRIID SIP Clinic. This open-label study represents a continuation of previous research conducted at USAMRIID. Subjects will be vaccinated with 0.5 mL of VEE vaccine, Live, Attenuated TC-83, NDBR 102, Lot 4, Run 3 subcutaneously in the upper outer aspect of the triceps region. Subjects will contacted the following day and weekly for 4 weeks to assess for adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
0.5 mL of VEE vaccine administered subcutaneously in the upper outer aspect of the triceps region.
Special Immunizations Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States
Safety: Occurrence of Serious Adverse Events and Adverse Events (SAEs and AEs)
Collect and assess safety data for VEE vaccine
Time frame: 15 months
Safety: Percentage of subjects with symptoms following VEE vaccination
Collect and assess safety data for VEE vaccine
Time frame: 15 months
Safety: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
Collect and assess safety data for VEE vaccine
Time frame: 15 months
Immunogenicity: Percentage of subjects who develop titers of >1:20
Percentage of subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are taken and over the entire study period to study completion.
Time frame: 15 months
Immunogenicity: Geometric Mean PRNT80 Titers of subjects
Geometric mean PRNT80 titers of subjects at each scheduled time point for which blood samples are taken and over the entire study period to study completion.
Time frame: 15 months
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