{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T02:11:53Z","timestamp":1778033513497,"version":"3.51.4"},"reference-count":46,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,7,14]],"date-time":"2024-07-14T00:00:00Z","timestamp":1720915200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The beneficial off\u2010target effects of Bacille Calmette\u2013Gu\u00e9rin (BCG) vaccination potentially include protection against allergy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>In the MIS BAIR trial, we aimed to determine whether neonatal BCG vaccination reduces atopic sensitisation and clinical food allergy in infants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this randomised controlled trial, 1272 neonates were allocated to BCG\u2010Denmark vaccine (0.05\u2009mL intradermal dose) or no BCG at birth. Randomisation was stratified by recruitment site, mode of delivery and plurality of birth. The primary outcome was the incidence of atopic sensitisation determined by skin prick test at 1\u2009year of age. Food allergy was determined by 3\u2010monthly online questionnaires and oral food challenges. Data were analysed by intention\u2010to\u2010treat using binary regression. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/bmjopen.bmj.com\/lookup\/external-ref?link_type=CLINTRIALGOV&amp;access_num=NCT01906853&amp;atom=%2Fbmjopen%2F9%2F12%2Fe032844.atom\">NCT01906853<\/jats:ext-link>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Atopic sensitisation during the first year of life was 22.9% among infants in the BCG group and 18.9% in the control group (adjusted risk difference (aRD) 3.8% (95% CI \u22121.5 to 9.1) after multiple imputation). Clinical food allergy was similar between infants in the BCG and control groups (9.8% vs. 9.6%; aRD 0.2, 95% CI \u22123.4 to 3.8). An interaction was observed between the primary outcome and maternal history of BCG vaccination. No interaction was observed for the additional prespecified potential effect modifiers tested (sex, delivery mode, family history of any allergy, season of birth, hepatitis B vaccination at randomisation, BCG scar and age at BCG administration).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Clinical Relevance<\/jats:title><jats:p>Neonatal BCG\u2010Denmark vaccination does not protect against atopic sensitisation or clinical food allergy in the first year of life.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.14537","type":"journal-article","created":{"date-parts":[[2024,7,15]],"date-time":"2024-07-15T00:35:19Z","timestamp":1721003719000},"page":"682-693","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial"],"prefix":"10.1111","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8404-4462","authenticated-orcid":false,"given":"Nicole\u00a0L.","family":"Messina","sequence":"first","affiliation":[{"name":"Infectious Diseases, Clinical Epidemiology &amp; 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