{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T12:42:42Z","timestamp":1793191362494,"version":"4.5.0"},"reference-count":28,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,1]]},"abstract":"<jats:sec>\n                    <jats:title\/>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>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\u00a0months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12\u00a0months 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>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\u00a0months 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\u00a0weeks and 3\u00a0months, irrespective of group, with modest differences in waning.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1542\/peds.2025-075223","type":"journal-article","created":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T00:02:43Z","timestamp":1777852963000},"source":"Crossref","is-referenced-by-count":10,"title":["Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial"],"prefix":"10.1542","volume":"157","author":[{"given":"Christina A.","family":"Rostad","sequence":"first","affiliation":[{"name":"1Children\u2019s Healthcare of Atlanta Arthur M. Blank Hospital, Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Mary","family":"Healy","sequence":"additional","affiliation":[{"name":"2Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer L.","family":"Nayak","sequence":"additional","affiliation":[{"name":"3UR Medicine, University of Rochester, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lalitha","family":"Parameswaran","sequence":"additional","affiliation":[{"name":"4NYU Grossman School of Medicine, New York University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Buddy","family":"Creech","sequence":"additional","affiliation":[{"name":"5Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith M.","family":"Martin","sequence":"additional","affiliation":[{"name":"6University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca C.","family":"Brady","sequence":"additional","affiliation":[{"name":"7University of Cincinnati College of Medicine, Cincinnati Children\u2019s Hospital Medical Center, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Jones-Beatty","sequence":"additional","affiliation":[{"name":"8University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Badell","sequence":"additional","affiliation":[{"name":"1Children\u2019s Healthcare of Atlanta Arthur M. Blank Hospital, Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Eppes","sequence":"additional","affiliation":[{"name":"2Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Quinn","sequence":"additional","affiliation":[{"name":"3UR Medicine, University of Rochester, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mulligan","sequence":"additional","affiliation":[{"name":"4NYU Grossman School of Medicine, New York University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie L.","family":"Rolsma","sequence":"additional","affiliation":[{"name":"5Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Marie","family":"Rick","sequence":"additional","affiliation":[{"name":"6University of Pittsburgh School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Braxton","family":"Forde","sequence":"additional","affiliation":[{"name":"7University of Cincinnati College of Medicine, Cincinnati Children\u2019s Hospital Medical Center, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasanthi","family":"Avadhanula","sequence":"additional","affiliation":[{"name":"9Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro A.","family":"Piedra","sequence":"additional","affiliation":[{"name":"9Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalyani","family":"Telu","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pratap S.","family":"Kunwar","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinjian","family":"Mu","sequence":"additional","affiliation":[{"name":"10The EMMES Company, LLC, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Gao","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcela F.","family":"Pasetti","sequence":"additional","affiliation":[{"name":"12University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Britta","family":"Flach","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine M.","family":"Posavad","sequence":"additional","affiliation":[{"name":"11Fred Hutchinson Cancer Center, Seattle, Washington"},{"name":"13University of Washington, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy","family":"Miedema","sequence":"additional","affiliation":[{"name":"14FHI 360, Washington, District of Columbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanna M.","family":"Piper","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, Bethesda, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonnie","family":"Kim","sequence":"additional","affiliation":[{"name":"15National Institutes of Health, 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during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study","volume":"25","author":"P\u00e9rez Marc","year":"2025","journal-title":"Lancet Infect Dis."},{"issue":"3","key":"2026101508414383300_r7","doi-asserted-by":"crossref","first-page":"EVIDoa2400275","DOI":"10.1056\/EVIDoa2400275","article-title":"Nirsevimab effectiveness at preventing RSV-related hospitalization in infants","volume":"4","author":"Jabagi","year":"2025","journal-title":"NEJM Evid."},{"issue":"3","key":"2026101508414383300_r8","doi-asserted-by":"crossref","first-page":"e250380","DOI":"10.1001\/jamanetworkopen.2025.0380","article-title":"Estimated effectiveness of nirsevimab against respiratory syncytial virus","volume":"8","author":"Xu","year":"2025","journal-title":"JAMA Netw Open."},{"issue":"13","key":"2026101508414383300_r9","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1056\/NEJMoa2502984","article-title":"Clesrovimab for prevention of RSV 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(Version 4.0 Dated 01\/04\/2020)","author":"Medicines & Healthcare Products Regulatory Agency; National Institute for Biological Standards and Control","year":"2020"},{"issue":"17","key":"2026101508414383300_r17","doi-asserted-by":"crossref","first-page":"1615","DOI":"10.1056\/NEJMoa2106062","article-title":"Prefusion F protein-based respiratory syncytial virus immunization in pregnancy","volume":"386","author":"Sim\u00f5es","year":"2022","journal-title":"N Engl J Med."},{"issue":"5","key":"2026101508414383300_r18","doi-asserted-by":"crossref","first-page":"1172","DOI":"10.1038\/s41591-023-02316-5","article-title":"Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants","volume":"29","author":"Wilkins","year":"2023","journal-title":"Nat 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