Scientific article

Prevention of infant eczema by neonatal bacille Calmette-Guérin vaccination: The MIS BAIR randomized controlled trial

Published inAllergy
Publication date2021-07-26
First online date2021-07-26

Background: Bacille Calmette-Guérin (BCG) vaccine could play a role in counteracting the rising prevalence of atopic diseases, through its beneficial off-target effects. We aimed to determine whether neonatal BCG vaccination reduces the incidence of eczema in infants.

Methods: Randomized controlled trial with 1272 infants allocated to receive BCG-Denmark or no BCG at birth. The primary outcome was the 12-month incidence of eczema based on 3-monthly questionnaires. Eczema was also assessed at a 12-month clinic visit. ClinicalTrial.gov: NCT01906853.

Results: The 12-month eczema incidence was 32.2% in the BCG group compared with 36.6% in the control group (adjusted risk difference (aRD) -4.3%, 95% CI -9.9% to 1.3%, multiple imputation model). In addition, comparing infants in the BCG group with the control group, 15.7% vs. 19.2% had eczema lesions at the 12-month visit (aRD -3.5%, 95% CI -8.0% to 1.0%); 35.7% vs. 39.0% reported using topical steroids (aRD -3.3, 95% CI -9.2 to 2.7); and 7.3% vs. 10.2% had severe eczema scores (aRD -3.0%, 95% CI -8.8% to 2.7%). In 344 high-risk infants (two atopic parents), the 12-month eczema incidence was 35.3% in the BCG group compared with 46.8% in the control group (aRD -11.5%, 95% CI -21.9% to -1.2%; number needed to treat 8.7, 95% CI 4.6 to 83.3).

Conclusion: There is insufficient evidence to recommend neonatal BCG vaccination in all infants for the prevention of eczema in the first year of life; however, a modest beneficial effect was observed among high-risk infants. A single dose of BCG-Denmark soon after birth could reduce the incidence of eczema in infants with two atopic parents.

  • Mycobacterium bovis
  • Atopic dermatitis
  • SCORing Atopic Dermatitis scoring system
  • William's UK diagnostic criteria
  • Patient-oriented eczema measure
  • Prevention
  • Vaccine non-specific effect
Affiliation Not a UNIGE publication
Citation (ISO format)
PITTET, Laure et al. Prevention of infant eczema by neonatal bacille Calmette-Guérin vaccination: The MIS BAIR randomized controlled trial. In: Allergy, 2021. doi: 10.1111/all.15022
Main files (1)
Article (Published version)
ISSN of the journal0105-4538

Technical informations

Creation11/26/2021 4:34:00 PM
First validation11/26/2021 4:34:00 PM
Update time03/16/2023 2:41:12 AM
Status update03/16/2023 2:41:10 AM
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