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Prevention of infant eczema by neonatal Bacillus Calmette-Guérin vaccination: The MIS BAIR randomized controlled
Laure F Pittet1,2,3, Nicole L Messina1,2, Kaya Gardiner1,4
1Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Insights
Neonatal Bacille Calmette-Guérin (BCG) vaccination did not significantly reduce eczema incidence in infants overall. However, BCG vaccination showed a modest benefit for high-risk infants with two atopic parents.
Area of Science:
- Immunology
- Pediatrics
- Public Health
Background:
- Atopic diseases, such as eczema, are increasingly prevalent.
- The Bacille Calmette-Guérin (BCG) vaccine, known for its off-target immunological effects, is being investigated for its potential role in managing atopic conditions.
- Neonatal BCG vaccination's impact on infant eczema requires further elucidation.
Purpose of the Study:
- To investigate the efficacy of neonatal BCG vaccination in preventing eczema among infants.
- To determine if BCG vaccination influences the 12-month incidence of eczema.
Main Methods:
- A randomized controlled trial involving 1272 infants was conducted.
- Infants were assigned to receive either BCG-Denmark vaccine or no BCG at birth.
- The primary outcome, eczema incidence, was assessed via questionnaires and a 12-month clinical visit.
Main Results:
- The overall 12-month eczema incidence was 32.2% in the BCG group versus 36.6% in the control group (aRD -4.3%).
- No significant differences were observed in eczema lesions, topical steroid use, or severe eczema scores between groups.
- In high-risk infants (two atopic parents), BCG vaccination reduced 12-month eczema incidence by 11.5% (aRD -11.5%, NNT 8.7).
Conclusions:
- Current evidence does not support routine neonatal BCG vaccination for all infants to prevent eczema.
- A potential modest protective effect of BCG vaccination against eczema was observed in high-risk infants.
- Single-dose BCG-Denmark soon after birth may reduce eczema incidence in infants with a strong family history of atopy.
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.
