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

Lisbeth Marianne Thøstesen, Jesper Kjaergaard, Gitte Thybo Pihl, Nina Marie Birk, Thomas Nørrelykke Nissen, Peter Aaby, Aksel Karl Georg Jensen, Annette Wind Olesen, Lone Graff Stensballe, Dorthe Lisbeth Jeppesen, Christine Stabell Benn, Poul-Erik Kofoed

Research output: Contribution to journalJournal articleResearchpeer-review


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).

Original languageEnglish
Issue number2
Pages (from-to)498-504
Publication statusPublished - Feb 2018


  • Journal Article
  • Bacillus Calmette-Guérin
  • infants
  • atopic dermatitis
  • heterologous immunity
  • randomized controlled trial
  • Humans
  • Infant
  • Male
  • BCG Vaccine/therapeutic use
  • Female
  • Dermatitis, Atopic/epidemiology
  • Netherlands/epidemiology
  • Infant, Newborn


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