NCT03051386

Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults

Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Live Attenuated, Dried, TC-83, NDBR 102, Lot 4, Run 3, as Primary Vaccination in Healthy Adult Subjects at Risk of Exposure to VEE Virus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Venezuelan Equine Encephalomyelitis Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	VEE Vaccine	0.5 mL of VEE vaccine administered subcutaneously in the upper outer aspect of the triceps region.

Timeline

• Start date: 2018-05-30
• Primary completion: 2022-04-01
• Completion: 2023-04-01
• First posted: 2017-02-13
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study