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

TY - JOUR

T1 - Neonatal BCG vaccination and atopic dermatitis before 13 months of age

T2 - A randomized clinical trial

AU - Thøstesen, L.M.

AU - Kjærgaard, J.

AU - Pihl, G.T.

AU - Birk, N.M.

AU - Nissen, T.N.

AU - Aaby, P.

AU - Jensen, A.K.G.

AU - Olesen, A.W.

AU - Stensballe, L.G.

AU - Jeppesen, D. L.

AU - Benn, C S

AU - Kofoed, P.-E.

N1 - © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

PY - 2018/2/1

Y1 - 2018/2/1

N2 - 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).

AB - 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).

U2 - 10.1111/all.13314

DO - 10.1111/all.13314

M3 - Journal article

C2 - 28929567

SN - 0105-4538

VL - 73

SP - 498

EP - 504

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

IS - 2

ER -