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

2022-03

Pittet, Laure F

Messina, Nicole L

Gardiner, Kaya

Freyne, Bridget

Abruzzo, Veronica

Francis, Kate L

Morrison, Clare

Zufferey, Christel

Vuillermin, Peter

Allen, Katrina J

Ponsonby, Anne-Louise

Robins-Browne, Roy

Shann, Frank

Flanagan, Katie L

Phillips, Rod

Donath, Susan

Casalaz, Dan

Curtis, Nigel

Mycobacterium bovis

Atopic dermatitis

SCORing Atopic Dermatitis scoring system

William's UK diagnostic criteria

patient-oriented eczema measure

prevention

vaccine non-specific effect

Journal Article

0000-0002-2395-4574

0000-0001-8404-4462

0000-0001-9796-4567

0000-0002-1751-5313

0000-0002-6580-0346

0000-0002-6581-3657

0000-0003-3446-4594

10.1111/all.15022

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. 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. 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). 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.

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Allergy 2022; 77(3): 956-965

Allergy