Chikungunya Virus Vaccine Trial in Healthy Adults
Condition: Viral Vaccines; Chikungunya Fever; Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache,
      muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint
      pain, which may be directly related to the infecting virus, may be severe and last for
      several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new
      experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy
      adults. Participants cannot develop CHIKV from this vaccine.

      Objectives:

      - To test the safety and effectiveness of a Chikungunya virus vaccine.

      Eligibility:

      - Healthy individuals between 18 and 50 years of age.

      Design:

        -  This study, including vaccine doses and followup tests, will last about 44 weeks.
           Participants will have three vaccination visits, six followup clinic visits, and three
           telephone contacts during this study. Vaccination visits will take about 4 hours. Most
           other clinic visits will usually take 2 hours. The telephone contacts will take about 15
           minutes.

        -  Participants will be screened with a physical exam and medical history. Blood samples
           will also be collected.

        -  Participants will be assigned to one of three dose groups. Information about doses will
           be provided before the start of the vaccinations.

        -  Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks.
           Participants will be asked to keep an eye on the injection site for 7 days and to notify
           researchers if there are any side effects.

        -  Participants will be monitored throughout the study with blood samples and clinic
           visits.
    

Detailed description: 
      This is a Phase I, open-label, dose-escalation study to examine the safety, tolerability, and
      immune response to a Virus-Like Particle (VLP) Chikungunya Virus (CHIKV) vaccine in healthy
      adults ages 18 to 50 years old. The plan is for 25 subjects to receive 3 intramuscular
      vaccine injections at weeks 0, 4, and 20. The three groups will be enrolled sequentially
      starting with the lowest dose of 10 micrograms per injection in Group 1.

      The hypothesis is that the vaccine is safe and induces immune responses to CHIKV. The primary
      objective is to evaluate the safety and tolerability of the investigational vaccine,
      VRC-CHKVLP059-00-VP, at three dosages, 10 micrograms (mcg), 20 mcg, and 40 mcg, in healthy
      adults. The secondary objective is to evaluate the antibody response against CHIKV VLPs four
      weeks after the third vaccine injection. The exploratory objectives relate to
      antigen-specific humoral and cellular immune responses throughout the study.
    

Intervention name(s): VRC-CHKVLP059-00-VP
Intervention type(s): Biological
Intervention description(s): VRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine-Mediated Protection; Antibody Response; Chikungunya Virus; Immune Response; Healthy Volunteer; Humoral Inmunity; Virus-like Particles