Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial

IF 6.3 2区医学 Q1 ALLERGY

Clinical and Experimental Allergy Pub Date : 2024-07-14 DOI:10.1111/cea.14537

Nicole L. Messina, Kaya Gardiner, Laure F. Pittet, Emily K. Forbes, Kate L. Francis, Bridget Freyne, Christel Zufferey, Veronica Abruzzo, Clare Morison, Hannah Turner, Katrina J. Allen, Katie L. Flanagan, Anne-Louise Ponsonby, Roy Robins-Browne, Frank Shann, Peter Vuillermin, Susan Donath, Dan Casalaz, Nigel Curtis, the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group

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引用次数: 0

Abstract

Background

The beneficial off-target effects of Bacille Calmette–Guérin (BCG) vaccination potentially include protection against allergy.

Objective

In the MIS BAIR trial, we aimed to determine whether neonatal BCG vaccination reduces atopic sensitisation and clinical food allergy in infants.

Methods

In this randomised controlled trial, 1272 neonates were allocated to BCG-Denmark vaccine (0.05 mL 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 year of age. Food allergy was determined by 3-monthly online questionnaires and oral food challenges. Data were analysed by intention-to-treat using binary regression. Clinicaltrials.gov (NCT01906853).

Results

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 −1.5 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 −3.4 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).

Conclusions and Clinical Relevance

Neonatal BCG-Denmark vaccination does not protect against atopic sensitisation or clinical food allergy in the first year of life.

Abstract Image

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新生儿接种卡介苗预防婴儿过敏：MIS BAIR 随机对照试验。

背景：卡介苗（Bacille Calmette-Guérin，BCG）接种的有益脱靶效应可能包括防止过敏：在 MIS BAIR 试验中，我们旨在确定新生儿接种卡介苗是否能减少婴儿的特应性过敏和临床食物过敏：在这项随机对照试验中，1272 名新生儿在出生时被分配接种卡介苗-丹麦疫苗（0.05 毫升皮内剂量）或不接种卡介苗。按照招募地点、分娩方式和多胎性进行了分层随机分配。主要结果是1岁时通过皮肤点刺试验确定特应性过敏的发生率。食物过敏通过 3 个月一次的在线问卷调查和口服食物挑战来确定。采用二元回归法对数据进行意向治疗分析。Clinicaltrials: gov (NCT01906853)：卡介苗组婴儿出生后第一年的特应性敏感率为22.9%，对照组为18.9%（多重归因后调整风险差异（aRD）为3.8%（95% CI-1.5至9.1））。卡介苗组和对照组婴儿的临床食物过敏情况相似（9.8% vs. 9.6%；aRD 0.2，95% CI -3.4-3.8）。主要结果与母亲卡介苗接种史之间存在交互作用。在测试的其他预设潜在效应调节因子（性别、分娩方式、家族过敏史、出生季节、随机接种时的乙肝疫苗、卡介苗疤痕和接种卡介苗的年龄）中未观察到交互作用：结论和临床意义：新生儿接种卡介苗不会在出生后第一年内预防特应性过敏或临床食物过敏。

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来源期刊

Clinical and Experimental Allergy 医学-过敏

CiteScore

10.40

自引率

9.80%

发文量

189

审稿时长

3-8 weeks

期刊介绍： Clinical & Experimental Allergy strikes an excellent balance between clinical and scientific articles and carries regular reviews and editorials written by leading authorities in their field. In response to the increasing number of quality submissions, since 1996 the journals size has increased by over 30%. Clinical & Experimental Allergy is essential reading for allergy practitioners and research scientists with an interest in allergic diseases and mechanisms. Truly international in appeal, Clinical & Experimental Allergy publishes clinical and experimental observations in disease in all fields of medicine in which allergic hypersensitivity plays a part.