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We aimed to evaluate the efficacy of neonatal BCG vaccination in preventing asthma by modulating early\u2010life immunity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:italic>Melbourne Infant Study: BCG for Allergy and Infection Reduction<\/jats:italic>\n                      (MIS BAIR) was a phase 3 multicentre randomized controlled trial in Victoria, Australia. Infants were randomly assigned to receive the BCG\u2010Denmark vaccine or no intervention within 10\u2009days of birth. The incidence of asthma at 5\u2009years of age was estimated using the International Study of Asthma and Allergies in Childhood questions.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrial.gov\">ClinicalTrial.gov<\/jats:ext-link>\n                      (NCT01906853).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 1272 infants were randomized. The adjusted incidence of asthma was 14.4% in the BCG group compared to 16.0% in the control group (adjusted risk difference [aRD] \u22121.7 percentage points; 95%CI \u22127.4, 3.9). Secondary outcomes, including severe asthma and use of preventer medication, showed similar trends, with an aRD of \u22123.9 (95%CI \u22127.7, 0.0), and \u22125.6 (95%CI \u221210.9, \u22120.4), respectively, favoring the BCG group. Among participants with one or both parents asthmatic, the rate of asthma was also lower in the BCG group (17.6%) compared with the control group (24.7%; aRD \u22127.2; 95%CI \u221215.9, 1.5), although a test for interaction was not significant (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.07).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>While the point estimates suggested BCG vaccination might protect against asthma, the wide uncertainty around the estimates means further studies with larger sample sizes are needed to evaluate the long\u2010term benefits of BCG vaccination beyond its primary indication.<\/jats:p>\n                  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