Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial

作者：Eric A. F. Simões, Barbara Pahud, Shabir A. Madhi, Beate Kampmann, Emma Shittu, David Radley, Conrado J. Llapur, Jeffrey T. Baker, Gonzalo Pérez Marc, 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, Uzma Sarwar, James Baber, Kenneth Koury, Maria Maddalena Lino, Elena Kalinina, Weiqiang Li, David Cooper, Annaliesa S. Anderson, Kena A. Swanson, Alejandra Gurtman, Iona Munjal · 发表于：Obstetrics and Gynecology · 年份：2025 · DOI：10.1097/aog.0000000000005816 · 被引用次数：109 · 研究领域：Respiratory viral infections research、COVID-19 Impact on Reproduction、Viral Infections and Outbreaks Research

OBJECTIVE: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF). METHODS: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose. Primary efficacy endpoints included newborn and infant severe RSV-associated medically attended lower respiratory tract illness within 180 days after birth. The RSV-A and RSV-B serum neutralizing antibody titers were determined in a subset of pregnant participants and their newborns. RESULTS: In this final analysis, 7,420 pregnant participants were randomized, and 7,307 children were born (RSVpreF n=3,660, placebo n=3,647). Vaccine efficacy , defined as protection against newborn and infant severe RSV-associated medically attended lower respiratory tract illness, was 82.4% (95% CI, 57.5-93.9) and 70.0% (95% CI, 50.6-82.5) within 90 and 180 days of birth, respectively. The RSVpreF induced robust immune responses in pregnant participants and resulted in highly efficient transfer of maternal antibodies to their newborns across subgroups (by gestational age at delivery and at vaccination, number of days from vac...