Clinical Trial: Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine in Healthy Adults

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Prim

Brief 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 Summary:

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.

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

Current Primary Outcome:

• Safety: Occurrence of Serious Adverse Events and Adverse Events (SAEs and AEs) [ Time Frame: 15 months ]
  Collect and assess safety data for VEE vaccine
• Safety: Percentage of subjects with symptoms following VEE vaccination [ Time Frame: 15 months ]
  Collect and assess safety data for VEE vaccine
• Safety: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination [ Time Frame: 15 months ]
  Collect and assess safety data for VEE vaccine

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Immunogenicity: Percentage of subjects who develop titers of >1:20 [ Time Frame: 15 months ]
  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.
• Immunogenicity: Geometric Mean PRNT80 Titers of subjects [ Time Frame: 15 months ]
  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.

Original Secondary Outcome: Same as current

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: February 9, 2017
Date Started: December 1, 2017
Date Completion: April 1, 2023
Last Updated: May 2, 2017
Last Verified: May 2017