A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)

Summary

The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent subjects.

Timeline

Start

2021-09-29

Primary completion

2023-04-03

Completion

2023-04-03

Outcome

Met primary endpoint

release “The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies” bavarian-nordic.com ↗

Publications

• Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016/S0140-6736(25)00345-9. Epub 2025 Mar 27.
• Miao Q, Nguyen W, Zhu J, Liu G, van Oers MM, Tang B, Yan K, Larcher T, Suhrbier A, Pijlman GP. A getah virus-like-particle vaccine provides complete protection from viremia and arthritis in wild-type mice. Vaccine. 2024 Nov 14;42(25):126136. doi: 10.1016/j.vaccine.2024.07.037. Epub 2024 Jul 14.
• Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.

Drugs

Indications