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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05072080
Study type Interventional
Source Emergent BioSolutions
Contact Pamela Young
Phone 650-486-0273
Email [email protected]
Status Recruiting
Phase Phase 3
Start date September 29, 2021
Completion date August 2022

See also
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Completed NCT02305732 - A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Completed NCT01489358 - Chikungunya Virus Vaccine Trial in Healthy Adults Phase 1
Completed NCT03325075 - Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects Phase 1