{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T04:06:40Z","timestamp":1788926800633,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T00:00:00Z","timestamp":1783555200000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019533","name":"Moderna, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019533","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>mRNA-1345 is a respiratory syncytial virus (RSV) vaccine approved for prevention of RSV-associated lower respiratory tract disease in individuals aged \u226560 years and those aged 18\u201359 years at high-risk of severe RSV disease. Protection offered by a single dose of an RSV vaccine is not expected to be lifelong, and data on revaccination are needed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This randomized, observer-blind, placebo-controlled, phase 3 study evaluated mRNA-1345 (50\u2005\u00b5g) revaccination approximately 24 months after primary vaccination in adults \u226560 years. Participants were randomized 2:1 to receive mRNA-1345 as a revaccination dose or placebo. Primary objectives were to assess safety and to demonstrate noninferiority of RSV-A and RSV-B neutralizing antibody (nAb) responses following revaccination compared with the primary dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 1502 participants received an injection at 24 months postprimary dose (mRNA-1345, n = 998; placebo, n = 504). mRNA-1345 revaccination was generally well tolerated, with injection-site pain, fatigue, myalgia, headache, arthralgia, and chills the most frequently reported, solicited adverse reactions. No safety concerns were identified. Noninferiority was demonstrated for the coprimary endpoints (RSV-A and RSV-B nAb responses) based on a prespecified noninferiority margin of 1.5; the lower bound of 95% CI for the geometric mean titer ratio (postrevaccination titer vs day 29 postprimary vaccination) was &amp;gt;1\/1.5 (approximately 0.667).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>mRNA-1345 revaccination at 24 months was well tolerated and elicited nAb responses noninferior to primary vaccination. Based on nAb titers comparable to those after primary vaccination, mRNA-1345 revaccination has the potential to provide extended protection against RSV disease once timing for revaccination is determined.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. NCT05127434 (https:\/\/clinicaltrials.gov\/study\/NCT05127434).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag350","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T11:39:31Z","timestamp":1783424371000},"source":"Crossref","is-referenced-by-count":1,"title":["Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 RSV Vaccine Administered 24 Months Following a Primary Dose in Adults \u226560 Years of Age"],"prefix":"10.1093","author":[{"given":"Mihir","family":"Desai","sequence":"first","affiliation":[{"name":"Infectious Disease, Clinical Development, Moderna, Inc. , Cambridge, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilberto","family":"Jimenez","sequence":"additional","affiliation":[{"name":"Spotlight Research Center , Miami, Florida 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