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Neonatal BCG vaccination and atopic dermatitis before 13 months of age: A randomized clinical trial: 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
  • Department of Clinical Immunology and Biochemistry, Lillebaelt Hospital, Vejle, Denmark.
  • Copenhagen University Hospital
  • Statens Serum Institut
  • University of Southern Denmark

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume73
Issue number2
Pages (from-to)498-504
Number of pages7
ISSN0105-4538
DOIs
Publication statusPublished - Feb 2018

Keywords

  • disease, health science and nursing

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