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NOT YET RECRUITING
NCT03531242
PHASE2

Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults

Sponsor: U.S. Army Medical Research and Development Command

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2021-06

Completion Date

2024-12

Last Updated

2021-02-16

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1

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

Locations (1)

Special Immunizations Program/USAMRIID

Fort Deterick, Maryland, United States