{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T07:44:36Z","timestamp":1794037476672,"version":"4.8.0"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,1,31]],"date-time":"2024-01-31T00:00:00Z","timestamp":1706659200000},"content-version":"vor","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":[],"published-print":{"date-parts":[[2024,9,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Respiratory syncytial virus (RSV) presents a global health concern. A lipid nanoparticle\u2013encapsulated mRNA-based RSV vaccine (mRNA-1345) that encodes the membrane-anchored RSV prefusion\u2013stabilized F glycoprotein is under clinical investigation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This phase 1 dose escalation study was based on a randomized, observer-blind, placebo-controlled design, and it assessed the safety and immunogenicity of mRNA-1345 in healthy adults aged 18 to 49 years. Participants were randomized to receive 1 dose of mRNA-1345 (50, 100, or 200\u2005\u00b5g) or placebo or 3 doses of mRNA-1345 (100\u2005\u00b5g) or placebo 56 days apart.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>mRNA-1345 was well tolerated at all dose levels. The most common solicited adverse reactions were pain, headache, fatigue, myalgia, or chills, which were all generally mild to moderate. At 1 month postinjection, a single injection of mRNA-1345 boosted RSV neutralizing antibody titers (geometric mean fold rise: RSV-A, 20.0\u201323.5; RSV-B, 11.7\u201316.0) and RSV prefusion binding antibody concentrations (geometric mean fold rise, 16.1\u201321.8), with no apparent dose response. Antibody levels remained above baseline through 6 months. Sequential doses of 100\u2005\u00b5g were well tolerated but did not further boost antibody levels.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A single mRNA-1345 injection demonstrated an acceptable safety profile in younger adults and induced a durable neutralizing antibody response, supporting its continued development.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>ClinicalTrials.gov NCT04528719.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae035","type":"journal-article","created":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T08:30:01Z","timestamp":1706776201000},"page":"e637-e646","source":"Crossref","is-referenced-by-count":36,"title":["Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial"],"prefix":"10.1093","volume":"230","author":[{"given":"Christine A","family":"Shaw","sequence":"first","affiliation":[{"name":"Moderna, Inc , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Runa","family":"Mithani","sequence":"additional","affiliation":[{"name":"Moderna, Inc , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archana","family":"Kapoor","sequence":"additional","affiliation":[{"name":"Moderna, Inc , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh","family":"Dhar","sequence":"additional","affiliation":[{"name":"Moderna, Inc , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Wilson","sequence":"additional","affiliation":[{"name":"Moderna, Inc , Cambridge, Massachusetts , 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