A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.

Summary

The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.

Timeline

Start

2025-06-05

Primary completion

2028-12

Completion

2028-12

Publications

• Background 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.
• Background McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9.
• Background 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.

Drugs

Indications