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Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial by Sean R Bennett; James M McCarty; Roshan Ramanathan; Jason Mendy; Jason S Richardson; Jonathan Smith; Jeff Alexander; Julie E Ledgerwood; Paul-André de Lame; Sarah Royalty Tredo; Kelly L Warfield; Lisa Bedell is a Medicine article available to read on EtoBox.
What is Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial about?
## Background: Chikungunya virus (chikv) disease is an ongoing public health threat. we aimed to evaluate the safety and immunogenicity of pxvx0317, an aluminium hydroxide-adjuvanted formulation of a chikv virus-like particle (vlp) vaccine. ## Methods: This randomised, double-blind, parallel-group, phase 2 trial was conducted at three clinical trial centres in the usa. eligible participants were healthy chikv-naïve adults aged 18-45 years. participants were stratified by site and randomly assigned (1:1:1:1:1:1:1:1) to one of the eight vaccination groups using a block size of 16. group 1 received two doses of unadjuvanted pxvx0317 28 days apart (2 × 20 μg; standard); all other groups received adjuvanted pxvx0317: groups 2-4 received two doses 28 days apart (2 × 6 μg [group 2], 2 × 10 μg [group 3], or 2 × 20 μg [group 4]; standard); group 4 also received a booster dose 18 months after the first active injection (40 μg; standard plus booster); groups 5-7 received two doses 14 days apart (2 × 6 μg [group 5], 2 × 10 μg [group 6], or 2 × 20 μg [group 7]; accelerated); and group 8 received one dose (1 × 40 μg; single). the primary endpoint was the geometric mean titre of anti-chikv neutra
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- Author
- Sean R Bennett; James M McCarty; Roshan Ramanathan; Jason Mendy; Jason S Richardson; Jonathan Smith; Jeff Alexander; Julie E Ledgerwood; Paul-André de Lame; Sarah Royalty Tredo; Kelly L Warfield; Lisa Bedell
- Publisher
- Elsevier BV
- Published
- 2022
- Language
- EN
- Field
- Medicine (Health Sciences)