drugset / Trial / NCT03483961

Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

NCT03483961 ↗

Phase 2 Completed 445 enrolled Bavarian Nordic Emergent BioSolutions · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults. Primary Objective: To assess the immune response to the vaccine Secondary Objectives: To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine Safety Objective: To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

Timeline

Start
2018-04-18
Primary completion
2020-09-14
Completion
2020-09-21

Drugs

EvaluationDrugModalityDoseRoute
Subject CHIKV VLP Vaccine 6 ug —
Subject CHIKV VLP Vaccine 10 ug —
Subject CHIKV VLP Vaccine 20 ug —
Subject CHIKV VLP Vaccine 40 ug —

Indications