drugset / Trial / NCT03483961
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CHIKV VLP | Vaccine | 6 ug | — |
| Subject | CHIKV VLP | Vaccine | 10 ug | — |
| Subject | CHIKV VLP | Vaccine | 20 ug | — |
| Subject | CHIKV VLP | Vaccine | 40 ug | — |