2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T6c7,Although both maternal respiratory syncytial virus (RSV) prefusion F vaccination (RSVpreF) and infant nirsevimab immunization have been approved for the prevention of RSV lower respiratory tract infections, the 2 have not been evaluated in a single study, and their sequential administration has not been studied systematically. We performed a prospective, randomized, open-label, phase 4 study at 8 US sites of mother-infant pairs randomized 1:1:1:1 during pregnancy: maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12 months to ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and -B neutralizing antibodies (nAbs). We report interim data from September 19, 2024, to May 15, 2025, including 4-month infant follow-up. In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning. Maternal RSVpreF vaccine and infant nirsevimab administration, either alone or in combination, were safe and provided high RSV nAb titers in infants through interim follow-up.31:T96d, BACKGROUND Although both maternal respiratory syncytial virus (RSV) prefusion F vaccination (RSVpreF) and infant nirsevimab immunization have been approved for the prevention of RSV lower respiratory tract infections, the 2 have not been evaluated in a single study, and their sequential administration has not been studied systematically. METHODS We performed a prospective, randomized, open-label, phase 4 study at 8 US sites of mother-infant pairs randomized 1:1:1:1 during pregnancy: maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12 months to ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and -B neutralizing antibodies (nAbs). We report interim data from September 19, 2024, to May 15, 2025, including 4-month infant follow-up. RESULTS In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning. CONCLUSIONS Maternal RSVpreF vaccine and infant nirsevimab administration, either alone or in combination, were safe and provided high RSV nAb titers in infants through interim follow-up. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Viral Vaccine: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Viral Vaccine (modality). Clinician-written summaries and actionable practice insights. Updated daily.\",\"url\":\"https://www.reachrx.ai/hub/tag/modality/Viral%20Vaccine\",\"breadcrumb\":{\"@type\":\"BreadcrumbList\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https://www.reachrx.ai\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Research Hub\",\"item\":\"https://www.reachrx.ai/hub\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Modalities\",\"item\":\"https://www.reachrx.ai/hub/tag/modality\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Viral Vaccine\",\"item\":\"https://www.reachrx.ai/hub/tag/modality/Viral%20Vaccine\"}]}}"}}]],["$","$L2f",null,{"title":"Viral Vaccine: Research & Clinical Takeaways","description":"Review evidence by treatment modality: Viral Vaccine — concise summaries and practical next steps.","papers":[{"doi":"10.1542/peds.2025-075223","pmid":"42070784","title":"Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial","journal_title":"Pediatrics","journal_issn":"0031-4005","published_at":"2026-05-04T00:00:00.000Z","url":"https://doi.org/10.1542/peds.2025-075223","source_score":18,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2026-05-07","doi":"10.1542/peds.2025-075223","days":"7","issn":"0031-4005","rank":"9","field":"Clinical Medicine","score":"18","category":"Pediatrics","categories":["Pediatrics"],"_categories":["Pediatrics"]},"pubmed":{"doi":"10.1542/peds.2025-075223","title":"Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial.","journal":"Pediatrics","methods":"","results":"In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning.","abstract":"$30","keywords":[],"pubmed_id":"42070784","conclusions":"","publication_date":"2026-05-04T00:00:00"},"crossref":{"DOI":"10.1542/peds.2025-075223","URL":"https://doi.org/10.1542/peds.2025-075223","ISSN":["0031-4005","1098-4275"],"link":[{"URL":"https://publications.aap.org/pediatrics/article-pdf/doi/10.1542/peds.2025-075223/1930604/pediatrics.2025075223.pdf","content-type":"application/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https://publications.aap.org/pediatrics/article-pdf/doi/10.1542/peds.2025-075223/1930604/pediatrics.2025075223.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial"],"author":[{"given":"Christina A.","family":"Rostad","sequence":"first","affiliation":[{"name":"1Children’s Healthcare of Atlanta Arthur M. Blank Hospital, Emory University School of Medicine, Atlanta, Georgia"}]},{"given":"C. Mary","family":"Healy","sequence":"additional","affiliation":[{"name":"2Baylor College of Medicine, Houston, Texas"}]},{"given":"Jennifer L.","family":"Nayak","sequence":"additional","affiliation":[{"name":"3UR Medicine, University of Rochester, Rochester, New York"}]},{"given":"Lalitha","family":"Parameswaran","sequence":"additional","affiliation":[{"name":"4NYU Grossman School of Medicine, New York University, New York, New York"}]},{"given":"C. Buddy","family":"Creech","sequence":"additional","affiliation":[{"name":"5Vanderbilt University Medical Center, Nashville, Tennessee"}]},{"given":"Judith M.","family":"Martin","sequence":"additional","affiliation":[{"name":"6University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania"}]},{"given":"Rebecca C.","family":"Brady","sequence":"additional","affiliation":[{"name":"7University of Cincinnati College of Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio"}]},{"given":"Kimberly","family":"Jones-Beatty","sequence":"additional","affiliation":[{"name":"8University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}]},{"given":"Martina","family":"Badell","sequence":"additional","affiliation":[{"name":"1Children’s Healthcare of Atlanta Arthur M. Blank Hospital, Emory University School of Medicine, Atlanta, Georgia"}]},{"given":"Catherine","family":"Eppes","sequence":"additional","affiliation":[{"name":"2Baylor College of Medicine, Houston, Texas"}]},{"given":"Michael","family":"Quinn","sequence":"additional","affiliation":[{"name":"3UR Medicine, University of Rochester, Rochester, New York"}]},{"given":"Mark","family":"Mulligan","sequence":"additional","affiliation":[{"name":"4NYU Grossman School of Medicine, New York University, New York, New York"}]},{"given":"Stephanie L.","family":"Rolsma","sequence":"additional","affiliation":[{"name":"5Vanderbilt University Medical Center, Nashville, Tennessee"}]},{"given":"Anne-Marie","family":"Rick","sequence":"additional","affiliation":[{"name":"6University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania"}]},{"given":"Braxton","family":"Forde","sequence":"additional","affiliation":[{"name":"7University of Cincinnati College of Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio"}]},{"given":"Vasanthi","family":"Avadhanula","sequence":"additional","affiliation":[{"name":"9Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas"}]},{"given":"Pedro A.","family":"Piedra","sequence":"additional","affiliation":[{"name":"9Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas"}]},{"given":"Kalyani","family":"Telu","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}]},{"given":"Pratap S.","family":"Kunwar","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}]},{"given":"Jinjian","family":"Mu","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}]},{"given":"Fei","family":"Gao","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"}]},{"given":"Marcela F.","family":"Pasetti","sequence":"additional","affiliation":[{"name":"12University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}]},{"given":"Britta","family":"Flach","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"}]},{"given":"Christine M.","family":"Posavad","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"},{"name":"13University of Washington, Seattle, Washington"}]},{"given":"Joy","family":"Miedema","sequence":"additional","affiliation":[{"name":"14FHI 360, Washington, District of Columbia"}]},{"given":"Jeanna M.","family":"Piper","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Sonnie","family":"Kim","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Tatiana","family":"Beresnev","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"Cristina","family":"Cardemil","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}]},{"given":"James D.","family":"Campbell","sequence":"additional","affiliation":[{"name":"8University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}]}],"issued":{"date-parts":[[2026,5,4]]},"member":"417","prefix":"10.1542","source":"Crossref","volume":null,"created":{"date-time":"2026-05-04T00:02:43Z","timestamp":1777852963000,"date-parts":[[2026,5,4]]},"indexed":{"date-time":"2026-05-05T02:50:52Z","timestamp":1777949452274,"date-parts":[[2026,5,5]]},"subject":[],"abstract":"$31","language":"en","relation":{},"resource":{"primary":{"URL":"https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2025-075223/207445/Maternal-RSV-Vaccination-Infant-Nirsevimab-or-Both"}},"subtitle":[],"deposited":{"date-time":"2026-05-04T00:02:47Z","timestamp":1777852967000,"date-parts":[[2026,5,4]]},"issn-type":[{"type":"print","value":"0031-4005"},{"type":"electronic","value":"1098-4275"}],"published":{"date-parts":[[2026,5,4]]},"publisher":"American Academy of Pediatrics (AAP)","reference":[{"DOI":"10.1542/peds.2023-061803","key":"2026050320023736100_r1","year":"2023","issue":"1","author":"Caserta","volume":"152","first-page":"e2023061803","unstructured":null,"article-title":"Palivizumab prophylaxis in infants and young children at increased risk of hospitalization for respiratory syncytial virus infection","journal-title":"Pediatrics.","doi-asserted-by":"crossref"},{"DOI":"10.15585/mmwr.mm7241e1","key":"2026050320023736100_r2","year":"2023","issue":"41","author":"Fleming-Dutra","volume":"72","first-page":"1115","unstructured":null,"article-title":"Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices - United States, 2023","journal-title":"MMWR Morb Mortal Wkly Rep.","doi-asserted-by":"crossref"},{"DOI":"10.15585/mmwr.mm7234a4","key":"2026050320023736100_r3","year":"2023","issue":"34","author":"Jones","volume":"72","first-page":"920","unstructured":null,"article-title":"Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices - United States, 2023","journal-title":"MMWR Morb Mortal Wkly Rep.","doi-asserted-by":"crossref"},{"DOI":"10.1056/NEJMoa2216480","key":"2026050320023736100_r4","year":"2023","issue":"16","author":"Kampmann","volume":"388","first-page":"1451","unstructured":null,"article-title":"Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants","journal-title":"N Engl J Med.","doi-asserted-by":"crossref"},{"DOI":"10.1056/NEJMoa2110275","key":"2026050320023736100_r5","year":"2022","issue":"9","author":"Hammitt","volume":"386","first-page":"837","unstructured":null,"article-title":"Nirsevimab for prevention of RSV in healthy late-preterm and term infants","journal-title":"N Engl J Med.","doi-asserted-by":"crossref"},{"DOI":"10.1016/S1473-3099(25)00156-2","key":"2026050320023736100_r6","year":"2025","issue":"9","author":"Pérez Marc","volume":"25","first-page":"1044","unstructured":null,"article-title":"Real-world effectiveness of RSVpreF vaccination during pregnancy against RSV-associated lower respiratory tract disease leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study","journal-title":"Lancet Infect Dis.","doi-asserted-by":"crossref"},{"DOI":"10.1056/EVIDoa2400275","key":"2026050320023736100_r7","year":"2025","issue":"3","author":"Jabagi","volume":"4","first-page":"EVIDoa2400275","unstructured":null,"article-title":"Nirsevimab effectiveness at preventing RSV-related hospitalization in infants","journal-title":"NEJM Evid.","doi-asserted-by":"crossref"},{"DOI":"10.1001/jamanetworkopen.2025.0380","key":"2026050320023736100_r8","year":"2025","issue":"3","author":"Xu","volume":"8","first-page":"e250380","unstructured":null,"article-title":"Estimated effectiveness of nirsevimab against respiratory syncytial virus","journal-title":"JAMA Netw Open.","doi-asserted-by":"crossref"},{"DOI":"10.1056/NEJMoa2502984","key":"2026050320023736100_r9","year":"2025","issue":"13","author":"Zar","volume":"393","first-page":"1292","unstructured":null,"article-title":"Clesrovimab for prevention of RSV disease in healthy infants","journal-title":"N Engl J Med.","doi-asserted-by":"crossref"},{"DOI":"10.15585/mmwr.mm7432a3","key":"2026050320023736100_r10","year":"2025","issue":"32","author":"Moulia","volume":"74","first-page":"508","unstructured":null,"article-title":"Use of clesrovimab for prevention of severe respiratory syncytial virus-associated lower respiratory tract infections in infants: recommendations of the Advisory Committee on Immunization Practices - United States, 2025","journal-title":"MMWR Morb Mortal Wkly Rep.","doi-asserted-by":"crossref"},{"DOI":"10.1542/peds.2024-070240","key":"2026050320023736100_r11","year":"2025","issue":"6","author":"Irving","volume":"155","first-page":"e2024070240","unstructured":null,"article-title":"Infant respiratory syncytial virus immunization coverage in the Vaccine Safety Datalink: 2023–2024","journal-title":"Pediatrics.","doi-asserted-by":"crossref"},{"DOI":"10.1542/peds.2019-3611","key":"2026050320023736100_r12","year":"2020","issue":"1","author":"Rha","volume":"146","first-page":"e20193611","unstructured":null,"article-title":"Respiratory syncytial virus-associated hospitalizations among young children: 2015–2016","journal-title":"Pediatrics.","doi-asserted-by":"crossref"},{"DOI":"10.1016/S0264-410X(03)00098-7","key":"2026050320023736100_r13","year":"2003","issue":"19–20","author":"Piedra","volume":"21","first-page":"2448","unstructured":null,"article-title":"Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: a multi-center trial in children with cystic fibrosis","journal-title":"Vaccine.","doi-asserted-by":"crossref"},{"DOI":"10.1093/infdis/jiv406","key":"2026050320023736100_r14","year":"2016","issue":"3","author":"Glenn","volume":"213","first-page":"411","unstructured":null,"article-title":"A randomized, blinded, controlled, dose-ranging study of a respiratory syncytial virus recombinant fusion (F) nanoparticle vaccine in healthy women of childbearing age","journal-title":"J Infect Dis.","doi-asserted-by":"crossref"},{"DOI":"10.1016/j.vaccine.2018.10.087","key":"2026050320023736100_r15","year":"2018","issue":"50","author":"McDonald","volume":"36","first-page":"7641","unstructured":null,"article-title":"Establishment of the first WHO International Standard for antiserum to respiratory syncytial virus: report of an international collaborative study","journal-title":"Vaccine.","doi-asserted-by":"crossref"},{"DOI":null,"key":"2026050320023736100_r16","year":"2020","issue":null,"author":"Medicines & Healthcare Products Regulatory Agency; National Institute for Biological Standards and Control","volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1056/NEJMoa2106062","key":"2026050320023736100_r17","year":"2022","issue":"17","author":"Simões","volume":"386","first-page":"1615","unstructured":null,"article-title":"Prefusion F protein-based respiratory syncytial virus immunization in pregnancy","journal-title":"N Engl J Med.","doi-asserted-by":"crossref"},{"DOI":"10.1038/s41591-023-02316-5","key":"2026050320023736100_r18","year":"2023","issue":"5","author":"Wilkins","volume":"29","first-page":"1172","unstructured":null,"article-title":"Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants","journal-title":"Nat Med.","doi-asserted-by":"crossref"},{"DOI":"10.1093/infdis/jiu316","key":"2026050320023736100_r19","year":"2014","issue":"10","author":"Chu","volume":"210","first-page":"1582","unstructured":null,"article-title":"Respiratory syncytial virus transplacental antibody transfer and kinetics in mother-infant pairs in Bangladesh","journal-title":"J Infect Dis.","doi-asserted-by":"crossref"},{"DOI":"10.1093/infdis/jix489","key":"2026050320023736100_r20","year":"2017","issue":"11","author":"Capella","volume":"216","first-page":"1398","unstructured":null,"article-title":"Prefusion F, postfusion F, G antibodies, and disease severity in infants and young children with acute respiratory syncytial virus infection","journal-title":"J Infect Dis.","doi-asserted-by":"crossref"},{"DOI":"10.1371/journal.pone.0008088","key":"2026050320023736100_r21","year":"2009","issue":"12","author":"Ochola","volume":"4","first-page":"e8088","unstructured":null,"article-title":"The level and duration of RSV-specific maternal IgG in infants in Kilifi Kenya","journal-title":"PLoS One.","doi-asserted-by":"crossref"},{"DOI":"10.1093/infdis/jiab315","key":"2026050320023736100_r22","year":"2022","issue":"7","author":"Koivisto","volume":"225","first-page":"1189","unstructured":null,"article-title":"Respiratory syncytial virus (RSV)-specific antibodies in pregnant women and subsequent risk of RSV hospitalization in young infants","journal-title":"J Infect Dis.","doi-asserted-by":"crossref"},{"DOI":"10.1016/S0264-410X(03)00355-4","key":"2026050320023736100_r23","year":"2003","issue":"24","author":"Piedra","volume":"21","first-page":"3479","unstructured":null,"article-title":"Correlates of immunity to respiratory syncytial virus (RSV) associated-hospitalization: establishment of minimum protective threshold levels of serum neutralizing antibodies","journal-title":"Vaccine.","doi-asserted-by":"crossref"},{"DOI":null,"key":"2026050320023736100_r24","year":"2023","issue":null,"author":"Centers for Disease Control and Prevention","volume":null,"first-page":null,"unstructured":null,"article-title":"Limited availability of nirsevimab in the United States—interim CDC recommendations to protect infants from respiratory syncytial virus (RSV) during the 2023–2024 respiratory virus season","journal-title":null,"doi-asserted-by":null},{"DOI":"10.1093/jpids/piad052","key":"2026050320023736100_r25","year":"2023","issue":"8","author":"Domachowske","volume":"12","first-page":"477","unstructured":null,"article-title":"Safety of re-dosing nirsevimab prior to RSV season 2 in children with heart or lung disease","journal-title":"J Pediatric Infect Dis Soc.","doi-asserted-by":"crossref"},{"DOI":"10.1038/s41467-023-40057-8","key":"2026050320023736100_r26","year":"2023","issue":"1","author":"Ahani","volume":"14","first-page":"4347","unstructured":null,"article-title":"Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials","journal-title":"Nat Commun.","doi-asserted-by":"crossref"},{"DOI":"10.1001/jamapediatrics.2025.5778","key":"2026050320023736100_r27","year":"2026","issue":"3","author":"Moline","volume":"180","first-page":"314","unstructured":null,"article-title":"Effectiveness and impact of maternal RSV immunization and nirsevimab on medically attended RSV in US children","journal-title":"JAMA Pediatr.","doi-asserted-by":"crossref"},{"DOI":"10.1001/jama.2025.24082","key":"2026050320023736100_r28","year":"2026","issue":"9","author":"Jabagi","volume":"335","first-page":"787","unstructured":null,"article-title":"Nirsevimab vs RSVpreF vaccine for respiratory syncytial virus-related hospitalization in newborns","journal-title":"JAMA.","doi-asserted-by":"crossref"}],"short-title":[],"article-number":"e2025075223","content-domain":{"domain":[],"crossmark-restriction":false},"original-title":[],"container-title":["Pediatrics"],"reference-count":28,"published-online":{"date-time":null,"timestamp":null,"date-parts":[[2026,5,4]]},"references-count":28,"short-container-title":[],"is-referenced-by-count":0},"unpaywall":{"doi":"10.1542/peds.2025-075223","is_oa":false,"title":"Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial","updated":"2026-05-05T11:59:32+00:00","published_date":"2026-05-04","best_oa_location":null}},"created_at":"2026-05-14T13:23:03.016Z","updated_at":"2026-05-14T15:13:26.918Z","tags":[{"paper_doi":"10.1542/peds.2025-075223","tag_type":"age_group","value":"infant","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"brand","value":"Abrysvo","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"brand","value":"Beyfortus","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"category","value":"Pediatrics","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"condition","value":"Respiratory Syncytial Virus Infection","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"generic","value":"nirsevimab","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"generic","value":"RSVpreF vaccine","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"modality","value":"Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"modality","value":"Vaccine","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"modality","value":"Viral Vaccine","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"sample_size","value":"n=181","value_numeric":181},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"Design is open-label phase 4; classification as a randomized controlled trial is based on randomization despite lack of blinding.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"Interim analysis with infant follow-up to 4 months; clinical RSV outcomes were not reported in the abstract.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"Published date (2026-05-04) is one day before today's date per the user — paper is very recently published and findings have not yet been widely replicated.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The brand name of RSVpreF vaccine (Abrysvo, Pfizer) is inferred from the product description; the paper does not explicitly name the brand in the provided abstract.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The study is not powered to detect differences in RSV lower respiratory tract infection rates — only immunogenicity and safety endpoints are reported.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"The total n reflects mothers enrolled; the number of infants was not explicitly stated.","value_numeric":null},{"paper_doi":"10.1542/peds.2025-075223","tag_type":"warning","value":"This is an interim analysis; 12-month clinical efficacy and full safety data are not yet available.","value_numeric":null}],"summaries":{"what_studied":"A prospective, randomized, open-label phase 4 trial at 8 US sites assigned pregnant participants and their infants 1:1:1:1 to maternal RSVpreF alone, maternal RSVpreF plus infant nirsevimab at birth, maternal RSVpreF plus infant nirsevimab at 3 months, or infant nirsevimab alone at birth, with planned 12‑month follow-up; this interim report includes infant data to 4 months.","key_result":"Among 181 mothers, no related serious adverse events occurred in mothers or infants; nirsevimab was well tolerated with only mild to moderate local and systemic reactogenicity. Maternal RSVpreF increased maternal RSV‑A neutralizing antibody titers 17.35‑fold at delivery with durability to 3 months; infant geometric mean transfer ratio of RSV‑A nAbs was >1.3 across groups, and infant RSV nAbs were high at 6 weeks and 3 months with modest waning.","limitations":"Open-label design. Interim analysis with infant follow-up only to 4 months, and outcomes reported focus on safety and neutralizing antibody responses rather than clinical RSV disease.","practice_takeaway":"Maternal RSVpreF vaccination and infant nirsevimab, alone or in sequence, were well tolerated and yielded high infant RSV neutralizing titers through 3 months in this interim analysis. Continue current practice while awaiting 12‑month clinical outcomes and durability data."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"modality","value":"Viral Vaccine"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Modalities","href":"/hub/tag/modality"},{"name":"Viral Vaccine"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"modality","hub_tag_value":"Viral Vaccine"}}}]]

Papers