{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T19:52:25Z","timestamp":1792007545767,"version":"4.4.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,29]],"date-time":"2025-01-29T00:00:00Z","timestamp":1738108800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In this phase 3 trial of an investigational maternal respiratory syncytial virus prefusion F protein\u2013based vaccine (RSVPreF3-Mat), a higher rate of preterm birth was observed in the vaccine (6.8%) versus the placebo group (4.9%). Trial enrollment and vaccination were stopped. Results of investigations into this safety signal were reported previously. Here, we describe end-of-trial efficacy, immunogenicity, and safety results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Women 18\u201349 years old were randomized 2:1 to receive 1 dose of RSVPreF3-Mat (n = 3557) or placebo (n = 1771) at 240\/7\u2013340\/7 weeks\u2019 gestation. Primary outcomes were any and severe medically assessed RSV-associated lower respiratory tract disease (MA-RSV-LRTD) in infants until 6 months postbirth and safety until 12 months postbirth. Other efficacy outcomes were evaluated, along with immunogenicity (until 6 months postpartum\/birth) and safety in mothers and infants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Efficacy (with 95% credible interval) in infants until 6 months postbirth was 65.5% (37.5%\u201382.0%) against any MA-RSV-LRTD, 69.0% (33.0%\u201387.6%) against severe MA-RSV-LRTD, and 50.1% (\u22123.6% to 75.8%) against RSV hospitalization; it waned over time thereafter. Efficacy against MA-RSV-LRTD was 47.8% (\u221225.8% to 77.3%) in low- and middle-income and 75.9% (46.1%\u201391.5%) in high-income countries. RSVPreF3-Mat induced a substantial increase in RSV-A neutralization titers in mothers, with efficient transplacental transfer of antibodies that persisted in infants until at least 6 months postbirth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Consistent with the high titers of transplacentally transferred antibodies, this trial suggests a reduced risk of any\/severe MA-RSV-LRTD and RSV hospitalization until 6 months postbirth in infants born to mothers immunized with RSVPreF3-Mat during pregnancy. However, vaccine development was terminated due to an identified preterm birth risk.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. NCT04605159.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf033","type":"journal-article","created":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T07:16:47Z","timestamp":1737703007000},"page":"e146-e155","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy, Immunogenicity, and Safety of an Investigational Maternal Respiratory Syncytial Virus Prefusion F Protein\u2013Based Vaccine"],"prefix":"10.1093","volume":"82","author":[{"given":"Peyman","family":"Banooni","sequence":"first","affiliation":[{"name":"Matrix Clinical Research , Los Angeles, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Gonik","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Wayne State University , Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6929-4903","authenticated-orcid":false,"given":"Cristina","family":"Epalza","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre , Madrid ,","place":["Spain"]},{"name":"Fundaci\u00f3n Biom\u00e9dica Investigaci\u00f3n Hospital 12 Octubre , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5351-0309","authenticated-orcid":false,"given":"Osvaldo","family":"Reyes","sequence":"additional","affiliation":[{"name":"Centro de Vacunaci\u00f3n e Investigaci\u00f3n, Panama City ,","place":["Panama"]},{"name":"Sistema Nacional de Investigaci\u00f3n , Panama City ,","place":["Panama"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7629-0636","authenticated-orcid":false,"given":"Shabir A","family":"Madhi","sequence":"additional","affiliation":[{"name":"South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace Devota","family":"Gomez-Go","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Mary Chiles General Hospital , Manila ,","place":["Philippines"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khalequ","family":"Zaman","sequence":"additional","affiliation":[{"name":"Matlab Health Research Centre, International Centre for Diarrheal Disease Research , Dhaka ,","place":["Bangladesh"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrado Juan","family":"Llapur","sequence":"additional","affiliation":[{"name":"Instituto de Maternidad y Ginecolog\u00eda Nuestra Se\u00f1ora de las Mercedes , Tucum\u00e1n 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Medicine, Meilahti Vaccine Research Center, Helsinki University and Helsinki University Hospital , Helsinki ,","place":["Finland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9291-260X","authenticated-orcid":false,"given":"Li-Min","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, National Taiwan University Hospital , Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marisa M\u00e1rcia","family":"Mussi-Pinhata","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Ribeir\u00e3o Preto Medical School, University of S\u00e3o Paulo , Ribeir\u00e3o Preto ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4760-4074","authenticated-orcid":false,"given":"Jonas","family":"Dewulf","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, AZ Groeninge Hospital , Kortrijk ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3270-7345","authenticated-orcid":false,"given":"Joanne M","family":"Langley","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Dalhousie University , Halifax, Nova Scotia ,","place":["Canada"]},{"name":"Canadian Center for Vaccinology, IWK Health Centre , Halifax, Nova Scotia ,","place":["Canada"]},{"name":"Nova Scotia Health , Halifax, Nova Scotia ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Seidl","sequence":"additional","affiliation":[{"name":"GSK , Munich ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Ota","sequence":"additional","affiliation":[{"name":"GSK , Rixensart, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Kirabo","sequence":"additional","affiliation":[{"name":"GSK , Wavre 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