{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T20:38:17Z","timestamp":1786739897764,"version":"build-2736575974"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T00:00:00Z","timestamp":1709856000000},"content-version":"vor","delay-in-days":24,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019533","name":"Moderna","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":[[2024,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Monovalent Omicron XBB.1.5\u2013containing vaccines were approved for coronavirus disease 2019 (COVID-19) 2023\u20132024 immunizations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This ongoing, open-label, phase 2\/3 study evaluated messenger RNA (mRNA)-1273.815 monovalent (50-\u00b5g Omicron XBB.1.5 spike mRNA) and mRNA-1273.231 bivalent (25-\u00b5g each Omicron XBB.1.5 and BA.4\/BA.5 spike mRNAs) vaccines, administered as fifth doses to adults who previously received primary series, third doses of an original mRNA COVID-19 vaccine, and fourth doses of an Omicron BA.4\/BA.5 bivalent vaccine. Interim safety and immunogenicity 29 days after vaccination are reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Participants (randomized 1:1) received 50-\u00b5g of mRNA-1273.815 (n = 50) or mRNA-1273.231 (n = 51); median intervals (interquartile range) from prior BA.4\/BA.5 bivalent doses were 8.2 (8.1\u20138.3) and 8.3 (8.1\u20138.4) months, respectively. Fold increases in neutralizing antibody (nAb) against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants from prebooster nAb levels were numerically higher against XBB.1.5, XBB.1.16, EG.5.1, BA.2.86, and JN.1 than BA.4\/BA.5, BQ.1.1, or D614G on day 29. Monovalent vaccine also cross-neutralized FL.1.5.1, EG.5.1, BA.2.86, HK.3.1, HV.1, and JN.1 variants in a participant subset (n = 20) 15 days after vaccination. Reactogenicity was similar to that of mRNA-1273 vaccines.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>XBB.1.5-containing mRNA-1273 vaccines elicit robust, diverse nAb responses against more recent SARS-CoV-2 variants, including JN.1, supporting the XBB.1.5-spike update for COVID-19 vaccines.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae067","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T15:07:31Z","timestamp":1707836851000},"page":"e279-e286","source":"Crossref","is-referenced-by-count":59,"title":["Interim Report of the Reactogenicity and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 XBB\u2013Containing Vaccines"],"prefix":"10.1093","volume":"230","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6254-1158","authenticated-orcid":false,"given":"Spyros","family":"Chalkias","sequence":"first","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nichole","family":"McGhee","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordan L","family":"Whatley","sequence":"additional","affiliation":[{"name":"Meridian Clinical Research , Baton Rouge, Louisiana , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon","family":"Essink","sequence":"additional","affiliation":[{"name":"Meridian Clinical Research , Omaha, Nebraska , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Brosz","sequence":"additional","affiliation":[{"name":"Meridian Clinical Research , Grand Island, Nebraska , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9399-2867","authenticated-orcid":false,"given":"Joanne E","family":"Tomassini","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bethany","family":"Girard","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darin K","family":"Edwards","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Wu","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arshan","family":"Nasir","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Lee","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura E","family":"Avena","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Feng","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiping","family":"Deng","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C","family":"Montefiori","sequence":"additional","affiliation":[{"name":"Department of Surgery, Duke University Medical Center , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey R","family":"Baden","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Brigham & Women's Hospital , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline M","family":"Miller","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rituparna","family":"Das","sequence":"additional","affiliation":[{"name":"Infectious Disease, Research and Development, Moderna , Cambridge, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,13]]},"reference":[{"key":"2024081523523566500_jiae067-B1","author":"US Food and Drug Administration."},{"key":"2024081523523566500_jiae067-B2","author":"US Food and Drug Administration."},{"key":"2024081523523566500_jiae067-B3","author":"US Food and Drug Administration."},{"key":"2024081523523566500_jiae067-B4"},{"key":"2024081523523566500_jiae067-B5","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1056\/NEJMoa2208343","article-title":"A bivalent Omicron-containing booster vaccine against COVID-19","volume":"387","author":"Chalkias","year":"2022","journal-title":"N Engl J Med"},{"key":"2024081523523566500_jiae067-B6","doi-asserted-by":"crossref","first-page":"5125","DOI":"10.1038\/s41467-023-38892-w","article-title":"Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19","volume":"14","author":"Chalkias","year":"2023","journal-title":"Nat Commun"},{"key":"2024081523523566500_jiae067-B7","doi-asserted-by":"crossref","first-page":"2325","DOI":"10.1038\/s41591-023-02517-y","article-title":"Original SARS-CoV-2 monovalent and Omicron BA.4\/BA.5 bivalent COVID-19 mRNA vaccines: phase 2\/3 trial interim results","volume":"29","author":"Chalkias","year":"2023","journal-title":"Nat Med"},{"key":"2024081523523566500_jiae067-B8","doi-asserted-by":"crossref","first-page":"1007","DOI":"10.1016\/S1473-3099(23)00295-5","article-title":"Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial","volume":"23","author":"Lee","year":"2023","journal-title":"Lancet Infect Dis"},{"key":"2024081523523566500_jiae067-B9","doi-asserted-by":"crossref","first-page":"119","DOI":"10.15585\/mmwr.mm7205e1","article-title":"Early estimates of bivalent mRNA booster dose vaccine effectiveness in preventing symptomatic SARS-CoV-2 infection attributable to Omicron BA.5- and XBB\/XBB.1.5-related sublineages among immunocompetent adults\u2014increasing community access to testing program, United States, December 2022-January 2023","volume":"72","author":"Link-Gelles","year":"2023","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2024081523523566500_jiae067-B10","doi-asserted-by":"crossref","first-page":"579","DOI":"10.15585\/mmwr.mm7221a3","article-title":"Estimates of bivalent mRNA vaccine durability in preventing COVID-19-associated hospitalization and critical illness among adults with and without immunocompromising conditions\u2014VISION Network, September 2022-April 2023","volume":"72","author":"Link-Gelles","year":"2023","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2024081523523566500_jiae067-B11","doi-asserted-by":"crossref","first-page":"1625","DOI":"10.15585\/mmwr.mm715152e2","article-title":"Early estimates of bivalent mRNA vaccine effectiveness in preventing COVID-19\u2013associated hospitalization among immunocompetent adults aged \u226565 years\u2014IVY Network, 18 states, September 8\u2013November 30, 2022","volume":"71","author":"Surie","year":"2022","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2024081523523566500_jiae067-B12","doi-asserted-by":"crossref","first-page":"1616","DOI":"10.15585\/mmwr.mm715152e1","article-title":"Early estimates of bivalent mRNA vaccine effectiveness in preventing COVID-19\u2013associated emergency department or urgent care encounters and hospitalizations among immunocompetent adults\u2014VISION network, nine states, September\u2013November 2022","volume":"71","author":"Tenforde","year":"2022","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2024081523523566500_jiae067-B13","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1038\/s41467-023-35815-7","article-title":"Effectiveness of mRNA-1273 vaccination against SARS-CoV-2 Omicron subvariants BA.1, BA.2, BA.2.12.1, BA.4, and BA.5","volume":"14","author":"Tseng","year":"2023","journal-title":"Nat Commun"},{"key":"2024081523523566500_jiae067-B14","author":"US Food and Drug Administration."},{"key":"2024081523523566500_jiae067-B15","doi-asserted-by":"crossref","DOI":"10.1101\/2023.08.22.23293434","article-title":"Safety and immunogenicity of XBB.1.5-containing mRNA vaccines.","volume-title":"medRxiv","author":"Chalkias"},{"key":"2024081523523566500_jiae067-B16","doi-asserted-by":"crossref","first-page":"1920","DOI":"10.1056\/NEJMoa2022483","article-title":"An mRNA vaccine against SARS-CoV-2\u2014 preliminary report","volume":"383","author":"Jackson","year":"2020","journal-title":"N Engl J Med"},{"key":"2024081523523566500_jiae067-B17","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1126\/science.abm3425","article-title":"Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial","volume":"375","author":"Gilbert","year":"2022","journal-title":"Science"},{"key":"2024081523523566500_jiae067-B18","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1016\/S1473-3099(23)00278-5","article-title":"Virological characteristics of the SARS-CoV-2 Omicron XBB.1.16 variant","volume":"23","author":"Yamasoba","year":"2023","journal-title":"Lancet Infect Dis"},{"key":"2024081523523566500_jiae067-B19","author":"Centers for Disease Control and Prevention."},{"key":"2024081523523566500_jiae067-B20","first-page":"6904","article-title":"Neutralization escape by SARS-CoV-2 Omicron subvariant BA.2.86.","volume-title":"Vaccine","author":"Lasrado","year":"2023"},{"key":"2024081523523566500_jiae067-B21","author":"World Health Organization."},{"key":"2024081523523566500_jiae067-B22","author":"Centers for Disease Control and Prevention."},{"key":"2024081523523566500_jiae067-B23","doi-asserted-by":"crossref","first-page":"592","DOI":"10.1038\/s41586-023-06025-4","article-title":"SARS-CoV-2 Omicron boosting induces de novo B cell response in humans","volume":"617","author":"Alsoussi","year":"2023","journal-title":"Nature"},{"key":"2024081523523566500_jiae067-B24","doi-asserted-by":"crossref","first-page":"e70","DOI":"10.1016\/S1473-3099(23)00744-2","article-title":"Fast evolution of SARS-CoV-2 BA.2\u00b786 to JN.1 under heavy immune pressure","volume":"24","author":"Yang","year":"2024","journal-title":"Lancet Infect Dis"},{"key":"2024081523523566500_jiae067-B25","author":"US Food and Drug Administration."},{"key":"2024081523523566500_jiae067-B26","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.1038\/s41591-021-01377-8","article-title":"Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection","volume":"27","author":"Khoury","year":"2021","journal-title":"Nat Med"},{"key":"2024081523523566500_jiae067-B27","first-page":"5851","article-title":"mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States","volume-title":"Nat Commun","author":"Tseng","year":"2023"},{"key":"2024081523523566500_jiae067-B28","author":"Centers for Disease Control and Prevention."}],"container-title":["The Journal of Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jid\/advance-article-pdf\/doi\/10.1093\/infdis\/jiae067\/57273859\/jiae067.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jid\/article-pdf\/230\/2\/e279\/58809171\/jiae067.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jid\/article-pdf\/230\/2\/e279\/58809171\/jiae067.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,15]],"date-time":"2024-08-15T23:54:47Z","timestamp":1723766087000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jid\/article\/230\/2\/e279\/7607093"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,13]]},"references-count":28,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,2,13]]},"published-print":{"date-parts":[[2024,8,16]]}},"URL":"https:\/\/doi.org\/10.1093\/infdis\/jiae067","relation":{},"ISSN":["0022-1899","1537-6613"],"issn-type":[{"value":"0022-1899","type":"print"},{"value":"1537-6613","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,8,15]]},"published":{"date-parts":[[2024,2,13]]}}}