drugset / Trial / NCT05349617
Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.
Timeline
- Start
- 2022-05-12
- Primary completion
- 2023-06-19
- Completion
- 2023-08-08
Outcome
Met primary endpoint
registry Group 1 - PXVX0317 vs Group 2 - Placebo; p <0.0001; Percent Difference 86.2 (95% CI 80 to 90.3) NCT05349617 ↗
registry Group 1 - PXVX0317 vs Group 2 - Placebo; p <0.0001; [GMT Ratio] 90 (95% CI 69 to 117) NCT05349617 ↗
paper The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met. PMID 40158524 ↗
release “The studies met their primary endpoints” bavarian-nordic.com ↗
Publications
- Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27.
- 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PXVX0317 | Vaccine | 40 ug | Intramuscular |