Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants

作者：Beate Kampmann, Shabir A. Madhi, Iona Munjal, Eric A. F. Simões, Barbara Pahud, Conrado J. Llapur, Jeffrey T. Baker, Gonzalo Pérez Marc, David Radley, Emma Shittu, Julia R. Glanternik, Hasra Snaggs, James Baber, Philip Zachariah, Shaun Barnabas, M. Bardett Fausett, Tyler Adam, Nicole Perreras, Marlies A. van Houten, Anu Kantele, Li‐Min Huang, Louis Bont, Takeo Otsuki, Sergio L. Vargas, Joanna Gullam, Bruce Tapiéro, Renato T. Stein, Fernando P. Polack, Heather J. Zar, Nina Breinholt Stærke, María Duron Padilla, Peter Richmond, Kenneth Koury, Katherine Schneider, Elena Kalinina, David Cooper, Kathrin U. Jansen, Annaliesa S. Anderson, Kena A. Swanson, William C. Gruber, Alejandra Gurtman · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2216480 · 被引用次数：993 · 研究领域：Respiratory viral infections research、COVID-19 Impact on Reproduction、Neonatal Respiratory Health Research

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 6...