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

Abstract

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.

• Authors: Laure F Pittet, Nicole L Messina, Kaya Gardiner, Bridget Freyne, Veronica Abruzzo, Kate L Francis, Clare Morrison, Christel Zufferey, Peter Vuillermin, Katrina J Allen, Anne-Louise Ponsonby, Roy Robins-Browne, Frank Shann, Katie L Flanagan, Rod Phillips, Susan Donath, Dan Casalaz, Nigel Curtis
• Journal: Allergy (Allergy) Vol. 77 Issue 3 Pg. 956-965 (03 2022) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 34309859 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Chemical References

• BCG Vaccine

Topics

• BCG Vaccine
• Dermatitis, Atopic (epidemiology, prevention & control)
• Eczema (epidemiology, prevention & control)
• Humans
• Infant
• Infant, Newborn
• Prevalence
• Vaccination