Neonatal BCG vaccination and atopic dermatitis before 13 months of age: a randomized clinical trial

LM Thøstesen, J Kjaergaard, GT Pihl, NM Birk… - Allergy, 2018 - Wiley Online Library
LM Thøstesen, J Kjaergaard, GT Pihl, NM Birk, TN Nissen, P Aaby, AKG Jensen, AW Olesen…
Allergy, 2018Wiley Online Library
Background Studies have suggested that Bacillus Calmette‐Guérin (BCG) vaccination may
reduce the risk of allergic diseases, including atopic dermatitis. Methods The Danish
Calmette Study was conducted 2012‐2015. Within 7 days of birth new‐borns were
randomised 1: 1 to BCG or no BCG. Exclusion criteria were gestational age< 32 weeks, birth
weight< 1000 g, known immunodeficiency or no Danish‐speaking parent. Data were
collected through telephone interviews and clinical examinations until 13 months. Results …
Background
Studies have suggested that Bacillus Calmette‐Guérin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis.
Methods
The Danish Calmette Study was conducted 2012‐2015. Within 7 days of birth new‐borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish‐speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months.
Results
Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR = 0.90 [95% confidence intervals 0.80‐1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74‐0.95)) and children without atopic predisposition (RR 1.09 [0.88‐1.37]) (test of no interaction, P = .04).
Conclusion
Among children with atopic predisposition, the number‐needed‐to‐treat with BCG to prevent one case of atopic dermatitis was 21 (12‐76).
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