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

Part of paid clinical trials in Fort Deterick, Maryland.

Sponsor: U.S. Army Medical Research and Development Command
Study ID: NCT03531242
Phase: PHASE2
Status: Not Yet Recruiting

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Conditions

Venezuelan Equine Encephalomyelitis

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Key Dates

Start date: Jun 30, 2021
Status verified: Feb 2021
Primary completion: Dec 31, 2023
Completion: Dec 31, 2024

Study Design

Enrollment: 500 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Arms

Experimental: Cohort A: Initial Non-responders to VEE TC-83 vaccinations
Venezuelan Equine Encephalomyelitis (VEE) 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.
Experimental: Cohort B: Responders to TC-83 or previous C-84 vaccinations
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

Primary Outcome Measure

Percentage of Subjects Who Develop titers of >1:20 [ Time Frame: Month 12-15 ]

Central Contacts

Anthony P Cardile, DO, MAJ
301-619-8833
[email protected]
Jennifer L Kalapaca, RN, BSN, CCRC
301-619-1962
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Special Immunizations Program/USAMRIID	Fort Deterick	Maryland	21702	Anthony P Cardile, DO, MAJ [email protected] 301-619-8833

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Special Immunizations Program/USAMRIID· Fort Deterick, MD