Clinical Trial: Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults

Brief Summary: This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2 injection vaccine Chikungunya virus (CHIKV) and virus like particle vaccine (CHIKV VLP) in healthy adults.

Detailed Summary:

This is a Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine regimen with Chikungunya virus (CHIKV) and virus like particle vaccine (CHIKV VLP) in healthy adults.

The hypothesis is that the vaccine regimen is safe and induces a neutralizing antibody response to CHIKV. The primary objectives are to evaluate safety and tolerability of a 2-injection investigational vaccine regimen of VRC-CHKVLP059-00-VP at 20 mcg compared to placebo (PBS) in healthy adults in CHIKV endemic areas. The secondary objective is to evaluate neutralizing antibody response in vaccine recipients. The exploratory objectives relate to assessing incidence of CHIKV infection in vaccine and placebo recipients, as well as antigen-specific humoral and cellular immune responses during the study.

The expected duration of time on the study per subject is approximately 72 weeks with vaccinations scheduled at Day 0 and Day 28.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Local Reactogenicity [ Time Frame: 7 days after injection ]
    Local reactogenicity signs and symptoms for 7 days after each injection
  • Systemic Reactogenicity [ Time Frame: 7 days after injection ]
    Systemic reactogenicity signs and symptoms for 7 days after each injection
  • Laboratory measures [ Time Frame: 4 weeks after last injection ]
    Laboratory measures of safety through 4 weeks after last injection
  • Adverse Events [ Time Frame: 4 weeks after last injection ]
    Adverse events through 4 weeks after last injection
  • Serious adverse events and new chronic medical conditions [ Time Frame: Through study completion, an average of 72 weeks after first injection ]
    Serious adverse events and new chronic medical conditions throughout the study


Original Primary Outcome: Same as current

Current Secondary Outcome: Antibody response to VRC-CHKVLP059-00-VP [ Time Frame: Week 8 ]

Antibody responses as measured by neutralization assay 4 weeks after last study injection


Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: September 21, 2015
Date Started: October 2015
Date Completion: December 2017
Last Updated: October 21, 2016
Last Verified: October 2016