Phase I Trial of Measles Vectored Chikungungya Vaccine

Summary

This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.

Timeline

Start

2017-05-30

Primary completion

2019-01-17

Completion

2019-01-17

Drugs

Indications