{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T19:25:07Z","timestamp":1790277907167,"version":"4.1.0"},"reference-count":0,"publisher":"European Respiratory Society (ERS)","license":[{"start":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T00:00:00Z","timestamp":1784764800000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011033","name":"Agencia Estatal de Investigaci\u00f3n","doi-asserted-by":"publisher","award":["IPT-20120639-090000"],"award-info":[{"award-number":["IPT-20120639-090000"]}],"id":[{"id":"10.13039\/501100011033","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Inmunotek S.L."}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2026,7,3]]},"abstract":"\n Background<\/jats:title>\n Respiratory infections are the primary trigger of acute exacerbations in COPD, yet preventive strategies remain limited. This study aims to evaluate the efficacy and safety of MV130, a sublingual mucosal vaccine, in preventing COPD exacerbations alongside maintenance therapy.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n A phase 3, multicentre, double-blind, placebo-controlled, randomised clinical trial included 198 subjects across seven hospitals in Spain, with 1:1 allocation to MV130 or placebo. Eligible patients had \u22653 moderate COPD exacerbations or\u22652 with at least one requiring hospitalisation in the previous year. Patients received MV130 (300 FTU) or placebo daily for 12\u2005months. The primary outcome, assessed in both intention-to-treat (ITT) and per-protocol (PP) populations, was the number of exacerbations over 18\u2005months (12\u2005months of treatment +6\u2005months follow-up). Secondary exploratory endpoints related to healthcare resource utilisation and medication use were also evaluated in the ITT population. Safety was also assessed in the ITT population. (ClinicalTrials.gov:\n NCT01842360<\/jats:ext-link>\n ; EudraCT: 2012-003253-28).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Between May 2013 and January 2018, 198 eligible participants (154 men, 44 women; 97 MV130, 101 placebo) were enrolled. Baseline COPD medication use was well balanced between the treatment groups. Median number of acute exacerbations in the ITT set was 3.0 [interquartile range, IQR, 1.0\u20135.0] for placebo\n versus<\/jats:italic>\n 2.0 [IQR, 1.0\u20133.0] for MV130 (p\n =<\/jats:italic>\n 0.001). MV130 reduced exacerbation rate from 2.68 to 1.87 events per patient-year (95% CI 0.44\u20131.18;\n p<\/jats:italic>\n <0.001). There were 229 adverse events (AEs) reported in 103 participants (52%), 113 (48.5%) in the placebo group and 116 (55.7%) in the MV130 group. Two AEs, urticaria (placebo) and pruritus (MV130), were non-serious and assessed as possibly related to the study medication.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n MV130 reduces moderate and severe COPD exacerbations, suggesting its potential role as an adjunct preventive therapy.<\/jats:p>\n <\/jats:sec>","DOI":"10.1183\/13993003.00027-2026","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T14:55:16Z","timestamp":1784818516000},"page":"2600027","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Prevention of COPD exacerbations with a mucosal trained immunity\u2013based vaccine (MV130): a randomised phase 3 trial"],"prefix":"10.1183","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8501-0117","authenticated-orcid":false,"given":"Luis Puente","family":"Maestu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3890-2742","authenticated-orcid":false,"given":"Myriam Calle","family":"Rubio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Benedetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walther Iv\u00e1n Gir\u00f3n","family":"Matute","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0552-2484","authenticated-orcid":false,"given":"Juan Luis Rodr\u00edguez","family":"Hermosa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"\u00c1lvarez-Sala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos Jos\u00e9 \u00c1lvarez","family":"Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Jes\u00fas Buend\u00eda","family":"Garc\u00eda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan Serra","family":"Battles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7227-2238","authenticated-orcid":false,"given":"Francisco Garc\u00eda","family":"R\u00edo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia Garc\u00eda","family":"de Pedro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Fern\u00e1ndez-P\u00e9rez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Rodr\u00edguez-Sainz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jimena G\u00f3mez","family":"P\u00e9rez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"de Miguel Diez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Caballero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Casanovas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"Subiza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Fern\u00e1ndez-Cruz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2026,7,23]]},"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.00027-2026","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T14:55:16Z","timestamp":1784818516000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.00027-2026"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,23]]},"references-count":0,"alternative-id":["10.1183\/13993003.00027-2026"],"URL":"https:\/\/doi.org\/10.1183\/13993003.00027-2026","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,23]]}}}