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Randomized Controlled Trial
. 2024 Sep;54(9):682-693.
doi: 10.1111/cea.14537. Epub 2024 Jul 14.

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

Nicole L Messina  1   2 , Kaya Gardiner  1   3 , Laure F Pittet  1   2   4 , Emily K Forbes  1 , Kate L Francis  1   2 , Bridget Freyne  1   2   5   6 , Christel Zufferey  1 , Veronica Abruzzo  1 , Clare Morison  1 , Hannah Turner  1 , Katrina J Allen  1 , Katie L Flanagan  7   8   9 , Anne-Louise Ponsonby  1   2 , Roy Robins-Browne  1   2 , Frank Shann  2 , Peter Vuillermin  1   10   11 , Susan Donath  1   2 , Dan Casalaz  12 , Nigel Curtis  1   2   3 ; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group
Affiliations
Randomized Controlled Trial

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

Nicole L Messina et al. Clin Exp Allergy. 2024 Sep.

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.

Keywords: BCG; atopic sensitisation; food allergy; food challenge; vaccine off‐target effects.

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References

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