Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial.

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Tác giả: Patrick Ajiboye, Deborah M Anderson, Lisa Bedell, Victoria A Jenkins, Tobi Loreth, Jason Mendy, Sufia Muhammad, Roshan Ramanathan, Jason S Richardson, Lauren C Tindale, Sarah Royalty Tredo

Ngôn ngữ: eng

Ký hiệu phân loại: 294.5486 Hinduism

Thông tin xuất bản: England : Lancet (London, England) , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 742393

BACKGROUND: Adults older than 65 years are at increased risk for atypical presentations of chikungunya disease, as well as for severe outcomes including death. METHODS: In this phase 3, randomised, double-blind, placebo-controlled, parallel-group trial, adults aged 65 years and older received a single intramuscular dose of Vimkunya (previously chikungunya virus virus-like particle vaccine) or placebo at ten sites in the USA. Participants, clinical site personnel, and the sponsor were masked to individual treatment assignments until all participants had completed their involvement in the trial and the database was cleaned and locked. Baseline and postvaccination chikungunya virus serum neutralising antibody (SNA) titres (NT FINDINGS: Between May 12 and Dec 2, 2022, 413 participants were recruited and randomly assigned (1:1) to receive the Vimkunya vaccine (n=206) or placebo (n=207). The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met. Vimkunya induced a protective seroresponse (SNA NT INTERPRETATION: We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up. FUNDING: Emergent BioSolutions and Bavarian Nordic.
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