Pittet Laure F, Forbes Emily K, Donath Susan, Francis Kate L, Gardiner Kaya, Flanagan Katie L, Ponsonby Anne-Louise, Robins-Browne Roy, Shann Frank, South Mike, Vuillermin Peter, Casalaz Dan, Curtis Nigel, Messina Nicole L
Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Pediatr Allergy Immunol. 2025 Jun;36(6):e70110. doi: 10.1111/pai.70110.
Asthma has a significant impact worldwide, but prevention strategies remain limited. We aimed to evaluate the efficacy of neonatal BCG vaccination in preventing asthma by modulating early-life immunity.
The Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) was a phase 3 multicentre randomized controlled trial in Victoria, Australia. Infants were randomly assigned to receive the BCG-Denmark vaccine or no intervention within 10 days of birth. The incidence of asthma at 5 years of age was estimated using the International Study of Asthma and Allergies in Childhood questions.
gov (NCT01906853).
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] -1.7 percentage points; 95%CI -7.4, 3.9). Secondary outcomes, including severe asthma and use of preventer medication, showed similar trends, with an aRD of -3.9 (95%CI -7.7, 0.0), and -5.6 (95%CI -10.9, -0.4), 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 -7.2; 95%CI -15.9, 1.5), although a test for interaction was not significant (p = .07).
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-term benefits of BCG vaccination beyond its primary indication.
哮喘在全球范围内具有重大影响，但预防策略仍然有限。我们旨在评估新生儿卡介苗接种通过调节早期免疫来预防哮喘的疗效。
墨尔本婴儿研究：卡介苗预防过敏和感染（MIS BAIR）是在澳大利亚维多利亚州进行的一项3期多中心随机对照试验。婴儿在出生后10天内被随机分配接受丹麦卡介苗疫苗或不进行干预。使用儿童哮喘和过敏国际研究问卷评估5岁时哮喘的发病率。
美国国立医学图书馆临床试验注册库（NCT01906853）。
共有1272名婴儿被随机分组。卡介苗组哮喘的校正发病率为14.4%，而对照组为16.0%（校正风险差[aRD]为-1.7个百分点；95%置信区间为-7.4，3.9）。包括重度哮喘和使用预防药物在内的次要结局显示出类似趋势，卡介苗组的aRD分别为-3.9（95%置信区间为-7.7，0.0）和-5.6（95%置信区间为-10.9，-0.4）。在父母一方或双方患有哮喘的参与者中，卡介苗组的哮喘发生率（17.6%）也低于对照组（24.7%；aRD为-7.2；95%置信区间为-15.9，1.5），尽管交互作用检验不显著（p = 0.07）。
虽然点估计表明卡介苗接种可能预防哮喘，但估计值周围的广泛不确定性意味着需要进行更大样本量的进一步研究，以评估卡介苗接种超出其主要适应证的长期益处。
