Clinical Trial: Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: A Phase 2 Open-Label, Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205 When Used as a Booster After TC-83 Primary Immunization in H

Brief Summary: The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.

Detailed Summary:

Study Objectives:

Primary:

To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series

Secondary:

To assess incidence of VEE infection in C-84 boosted personnel.

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

Current Primary Outcome:

• Safety [ Time Frame: Day 28 after each booster dose ]
  Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.
• Immunogenicity: TC-83 with PRNT80 ≥ 1:20 [ Time Frame: Between Days 28 and 35 after each booster dose ]
  Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
• Immunogenicity: TC-83 with PRNT80 ≥ 1:20 [ Time Frame: 12-15 months after booster dose ]
  Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
• Immunogenicity: TC-83 with PRNT80 < 1:20 [ Time Frame: Between Days 28 and 35 after each booster dose ]
  Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
• Immunogenicity: TC-83 with PRNT80 < 1:20 [ Time Frame: 12-15 months after vaccination ]
  Number of initial responders to TC-83 who are non-responders (PRNT80 < 1:20) to C-84 booster dose.
• Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses [ Time Frame: After three booster doses ]
• Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose [ Time Frame: 12- 15 months after first booster dose ]
• Immunogenicity: PRNT80 ≥
  
  

  Original Primary Outcome: Safety: Frequency adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth. Immunogenicity: Measured by the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through 28 days after each booster dose; SAEs recorded for study duration; Immunogencity:PRNT80 at days 21 and 35 after each booster dose and 12-15 months after vaccination ]
  
  

  Current Secondary Outcome: VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. [ Time Frame: Length of the study ]

  The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80

  ≥ 1:20.

  
  
  

  Original Secondary Outcome: Safety: Frequency of all other adverse events for all intent-to-treat subjects; Immunogenicity: Frequency of confirmed cases of VEE disease among vaccinated subjects compliant with titer schedule with documented exposure after working with VEE virus. [ Time Frame: Safety: AE's: 28 days after vaccination; SAE's: duration of study; Immunogenicity: duration of study ]
  
  Information By: U.S. Army Medical Research and Materiel Command
  

  Dates:
  Date Received: December 19, 2007
  Date Started: January 2008
  Date Completion: June 2018
  Last Updated: May 2, 2017
  Last Verified: May 2017