Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.
Eric A F Simões, Barbara A Pahud, Shabir A Madhi, Beate Kampmann, Emma Shittu, David Radley, Conrado Llapur, Jeffrey Baker, Gonzalo Pérez Marc, Shaun L Barnabas, Merlin Fausett, Tyler Adam, Nicole Perreras, Marlies A Van Houten, Anu Kantele, Li-Min Huang, Louis J Bont, Takeo Otsuki, Sergio L Vargas, Joanna Gullam, Bruce Tapiero, Renato T Stein, Fernando P Polack, Heather J Zar, Nina B Staerke, María Duron Padilla, Peter C Richmond, Uzma N Sarwar, James Baber, Kenneth Koury, Maria Maddalena Lino, Elena V Kalinina, Weiqiang Li, David Cooper, Annaliesa S Anderson, Kena A Swanson, Alejandra Gurtman, Iona Munjal
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引用次数: 0
Abstract
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 vaccination to delivery, country, maternal age). Final RSVpreF safety results in pregnant and newborn and infant participants were consistent with the primary analysis with no new safety concerns identified.
Conclusion: This final analysis of MATISSE trial data confirms the primary analysis conclusions: Maternal vaccination with RSVpreF has a favorable safety profile in both pregnant and newborn and infant participants and demonstrates efficacy against RSV-associated lower respiratory tract illness in infants through age 6 months. The RSVpreF induces robust immune responses in pregnant individuals, with corresponding high RSV-neutralizing titers in their newborns.
期刊介绍：
"Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics.
"Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.
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