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

NCT02562482 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-10-22

Study results available
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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) virus-like particle vaccine (CHIKV VLP) in healthy adults.

Conditions

  • Chikungunya Virus Infection

Interventions

BIOLOGICAL

VRC-CHKVLP059-00-VP

VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).

OTHER

VRC-PBSPLA043-00-VP

VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Nicolas Rosario, MD · San Juan Hospital

  • Clemente Diaz, MD · Puerto Rico Clinical and Translational Research Consortium

  • Bruno Hoen, MD · University Hospital Pointe-a-Pitre, Guadeloupe

  • Yeycy Donastorg, MD · Instituto Dermatológico y Cirugía de Piel

  • Jean W Pape, MD · Centres GHESKIO, Haiti

  • Andre Cabie, MD · Centre Hospitalier Universitaire (CHU), Martinique

  • Julie Ledgerwood, DO · VRC, NIAID, NIH

  • Grace Chen, MD · VRC, NIAID, NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2018-03-06
Completion
2018-03-06
FDA Drug
Yes

Countries

  • Dominican Republic
  • Guadeloupe
  • Haiti
  • Martinique
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02562482 on ClinicalTrials.gov