Last updated on July 2019

Chikungunya Vaccine Study in Previously Exposed Adults

Brief description of study

Safety and immunogenicity of an investigational chikungunya vaccine will be tested in subjects with history of chikungunya infection. Initially 21 to 50 year old subjects will be enrolled; after favorable review of safety data, subjects aged 51 to 65 will be enrolled.

Detailed Study Description

This will be a prospective randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of an investigational live recombinant measles-vectored chikungunya vaccine (MV-CHIK) delivered in 2 vaccinations, 28 days apart compared with saline placebo. After providing informed consent, individuals will be screened for eligibility including verification of previous exposure to chikungunya virus. They will then be randomized in a double-blind fashion to receive either MV-CHIK or saline placebo in a 1:1 ratio. This study will be conducted in two Steps, first in up to 30 individuals ages 21 to 50. Then, pending a favorable review of the available vaccine safety data, in up to 30 individuals ages 51 to 65.

Clinical Study Identifier: NCT03807843

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San Juan Hospital, Research Unit

San Juan, Puerto Rico
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