Chikungunya Virus Clinical Trial
A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 in healthy adult and adolescent subjects.
Primary Objectives: 1. To evaluate the safety of PXVX0317 in healthy adult and adolescent subjects 12 to <65 years of age. 2. To compare the chikungunya virus (CHIKV) serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate. 3. To demonstrate the consistency of the CHIKV SNA response across three lots of PXVX0317 at Day 22. Secondary Objectives: 1. To compare the CHIKV SNA response to PXVX0317 and placebo at Day 8, Day 15, and Day 183. 2. To compare the CHIKV SNA response to PXVX0317 and placebo in subjects 12 to <18 years of age, subjects 18 to <46 years of age, and subjects 46 to <65 years of age. ;