NCT03807843

Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)

Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Themis Bioscience GmbH · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.

Detailed description

This will be a randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of the investigational V184 live recombinant measles-vectored chikungunya vaccine 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 V184 or saline placebo in a 1:1 ratio.

Conditions

• Chikungunya Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V184	Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10\^5 TCID50 (+/- 0.5 log) per dose.
OTHER	Placebo	Sterile physiological saline for IM injection

Timeline

• Start date: 2019-07-16
• Primary completion: 2021-05-13
• Completion: 2021-05-13
• First posted: 2019-01-17
• Last updated: 2022-09-08
• Results posted: 2022-05-16

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study