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Clinical & Experimental Allergy

Bacille–Calmette–Guerin vaccination and the development of allergic disease in children: a randomized, prospective, single-blind study

Authors

  • T. J. Steenhuis,

    1. Department of General Paediatrics, Wilhelmina's Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands,
    2. Department of Paediatric Pulmonology, Emma Children's Hospital AMC, Amsterdam, The Netherlands,
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  • W. M. C. Van Aalderen,

    1. Department of Paediatric Pulmonology, Emma Children's Hospital AMC, Amsterdam, The Netherlands,
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  • N. Bloksma,

    1. Department of Pharmacology and Pathophysiology, Utrecht Institute for Pharmaceutical Sciences,
    2. Faculty of Biology, Utrecht University, Utrecht, The Netherlands,
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  • F. P. Nijkamp,

    1. Department of Pharmacology and Pathophysiology, Utrecht Institute for Pharmaceutical Sciences,
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  • J. Van Der Laag,

    1. Department of Paediatric Pulmonology, Wilhelmina's Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands,
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  • H. Van Loveren,

    1. National Institute of Public Health and Environmental Protection (RIVM), Bilthoven, The Netherlands
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  • G. T. Rijkers,

    1. Department and Laboratory of Paediatric Immunology, Wilhelmina Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands
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  • W. Kuis,

    1. Department and Laboratory of Paediatric Immunology, Wilhelmina Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands
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  • M. O. Hoekstra

    1. Department of General Paediatrics, Wilhelmina's Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands,
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Correspondence:
M. O. Hoekstra, Department of General Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht (UMCU), PO Box 85090, 3508 AB Utrecht, The Netherlands.
E-mail: m.o.hoekstra@umcutrecht.nl

Summary

Background The increase in the prevalence of allergic diseases in countries with a so-called western lifestyle may be due to a decrease in exposure to infectious agents in early life.

Objective To establish the effect of Bacille–Calmette–Guerin (BCG) vaccination in 6-week-old high-risk infants in a prospective single-blind, randomized, placebo-controlled trial on the prevalence of allergic disease at the age of 4 and 18 months.

Methods Subjects were 121 predominantly Caucasian high-risk newborns, having either a mother, or both a father and at least one sibling with past or present allergic disease. BCG or placebo was administered at the age of 6 weeks, and repeated once when both a post-vaccination scar and a positive TB skin test were absent at the age of 4 months.

Results At the age of 18 months, the prevalence of allergic disease was not significantly different between the two groups. A trend towards less eczema (P=0.07) and significantly less use of medication for eczema was shown in the BCG group compared with the placebo group (P=0.04).

Conclusion A single (or once repeated) BCG vaccination in 6-week-old high-risk Caucasian infants was not associated with a 50% reduction in the prevalence of allergic disease. However, there could be a smaller beneficial effect of BCG, especially because a trend towards less eczema and significantly less use of medication for eczema was shown. For definite proof, a larger study should be carried out.

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