Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)

Phase 2 Completed 60 enrolled Bavarian Nordic Emergent BioSolutions · collab Walter Reed Army Institute of Research (WRAIR) · collab

Non-randomizedParallel-groupOpen-labelPrevention

Summary

This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.

Timeline

Start: 2019-11-20
Primary completion: 2021-01-19
Completion: 2021-01-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Experimental: Prior Alpha vs Control: Naive Alpha; p = 1; Mean Difference (Final Values) 0.0 (95% CI -11.4 to 11.4); Fisher Exact NCT03992872 ↗

Publications

Hamer MJ, McCarty JM, Pierson BC, Regules JA, Mendy J, Sanborn AD, Gardner CL, Haller JM, Gregory MK, Liggett DL, Glass PJ, Ghosh N, Royalty Tredo S, Warfield KL, Burke CW, Lee C, Saunders D, Bedell L, Richardson JS. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. Lancet Microbe. 2025 Apr;6(4):101000. doi: 10.1016/j.lanmic.2024.101000. Epub 2025 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PXVX0317	Vaccine	40 ug	Intramuscular