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Neonatal BCG-vaccination has no effect on recurrent wheeze in the first year of life. A randomized clinical trial

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  • Lisbeth Marianne Thøstesen
  • Lone Graff Stensballe
  • Gitte Thybo Pihl
  • Jesper Kjærgaard
  • Nina Marie Birk
  • Thomas Nørrelykke Nissen
  • Aksel Karl Georg Jensen
  • Peter Aaby
  • Annette Wind Olesen
  • Dorthe Lisbeth Jeppesen
  • Christine Stabell Benn
  • Poul-Erik Kofoed
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BACKGROUND: Recurrent wheeze is frequent in childhood. Studies have suggested that Bacillus Calmette-Guérin (BCG) vaccination may have non-specific effects, reducing general non-tuberculosis morbidity, including respiratory infections and atopic diseases. The mechanisms behind these non-specific effects of BCG are not fully understood, but a shift from Th2 to Th1-response has been suggested as a possible explanation.

OBJECTIVE: We hypothesized that BCG at birth would reduce the cumulative incidence of recurrent wheeze during the first year of life.

METHODS: The Danish Calmette Study is a multicenter randomized trial conducted from 2012-2015 at three Danish hospitals. The 4262 newborns of 4184 included mothers were randomized 1:1 to BCG (SSI strain 1331) or to a no-intervention control group within 7 days of birth; siblings were randomized together as one randomization unit. Exclusion criteria were gestational age <32 weeks, birth weight <1000g, known immunodeficiency, or no Danish-speaking parent. Information was collected through telephone interviews and clinical examinations at 3 and 13 months of age; the data collectors were blinded to randomization group. Recurrent wheeze was defined in several ways, the main definition being: "physician-diagnosed and medically treated recurrent wheeze up to 13 months of age".

RESULTS: By 13 months 211/2100 (10.0%) children in the BCG group and 195/2071 (9.4%) children in the control group had been diagnosed by a medical doctor with recurrent wheeze and received anti-asthmatic treatment (relative risk 1.07 (95% confidence intervals 0.89-1.28)). Supplementary analyses were made, including an analysis of baseline risk factors for developing RW.

CONCLUSION: Neonatal BCG had no effect on the development of recurrent wheeze before 13 months of age.

Original languageEnglish
JournalThe Journal of allergy and clinical immunology
Issue number6
Pages (from-to)1616-1621
Publication statusPublished - 1 Dec 2017

    Research areas

  • Journal Article

ID: 50158892