Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults

作者：Edward E. Walsh, Gonzalo Pérez Marc, Agnieszka Zareba, Ann R. Falsey, Qin Jiang, Michael Quinn Patton, Fernando P. Polack, Conrado J. Llapur, Pablo A. Doreski, Kumar Ilangovan, Mika Rämet, Yasushi Fukushima, Nazreen Hussen, Louis Bont, Jose F Cardona, Elliot DeHaan, Giselle Castillo Villa, Marinela Ingilizova, Daniel Eiras, Tarek Mikati, Rupal N. Shah, Katherine Schneider, David Cooper, Kenneth Koury, Maria-Maddalena Lino, Annaliesa S. Anderson, Kathrin U. Jansen, Kena A. Swanson, Alejandra Gurtman, William C. Gruber, Beate Schmöele-Thoma · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2213836 · 被引用次数：681 · 研究领域：Respiratory viral infections research、COVID-19 Clinical Research Studies、SARS-CoV-2 detection and testing

BACKGROUND: Respiratory syncytial virus (RSV) infection causes considerable illness in older adults. The efficacy and safety of an investigational bivalent RSV prefusion F protein-based (RSVpreF) vaccine in this population are unknown. METHODS: In this ongoing, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults (≥60 years of age) to receive a single intramuscular injection of RSVpreF vaccine at a dose of 120 μg (RSV subgroups A and B, 60 μg each) or placebo. The two primary end points were vaccine efficacy against seasonal RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms. The secondary end point was vaccine efficacy against RSV-associated acute respiratory illness. RESULTS: At the interim analysis (data-cutoff date, July 14, 2022), 34,284 participants had received RSVpreF vaccine (17,215 participants) or placebo (17,069 participants). RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group (1.19 cases per 1000 person-years of observation) and 33 participants in the placebo group (3.58 cases per 1000 person-years of observation) (vaccine efficacy, 66.7%; 96.66% confidence interval [CI], 28.8 to 85.8); 2 cases (0.22 cases per 1000 person-years of observation) and 14 cases (1.52 cases per 1000 person-years of observation), respectively, occurred with at least three signs or symptoms (vaccine efficacy, 85.7%; 96.66% CI, 32.0 to 98.7). RSV-associ...