Prevention of infant eczema by neonatal Bacillus Calmette‐Guérin vaccination: The MIS BAIR randomized controlled trial
| Autor: | Roy M. Robins-Browne, Anne-Louise Ponsonby, Nigel Curtis, Bridget Freyne, Peter Vuillermin, Katrina J. Allen, Kate L Francis, Rod Phillips, Veronica Abruzzo, Susan Donath, Dan Casalaz, Frank Shann, Kaya Gardiner, Nicole L Messina, Clare Morrison, Katie L. Flanagan, Christel Zufferey, Laure F Pittet |
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| Rok vydání: | 2021 |
| Předmět: |
Pediatrics
medicine.medical_specialty Allergy Immunology Eczema Patient-oriented eczema measure Dermatitis Atopic law.invention Vaccine non-specific effect Randomized controlled trial law Prevalence medicine Humans SCORing Atopic Dermatitis scoring system Immunology and Allergy William's UK diagnostic criteria ddc:610 SCORAD Atopic dermatitis medicine.diagnostic_test business.industry Prevention Incidence (epidemiology) Vaccination Infant Newborn Absolute risk reduction Infant medicine.disease Mycobacterium bovis BCG Vaccine Number needed to treat business |
| Zdroj: | Allergy (2021) |
| ISSN: | 1398-9995 0105-4538 |
| DOI: | 10.1111/all.15022 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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