title: Bacille-Calmette-Guerin vaccination and the development of allergic disease in children: a randomized, prospective, single-blind study.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of General Paediatrics, Wilhelmina's Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands.
authors.forename: T J
authors.initials: TJ
authors.lastname: Steenhuis
authors.forename: W M C
authors.initials: WM
authors.lastname: van Aalderen
authors.forename: N
authors.initials: N
authors.lastname: Bloksma
authors.forename: F P
authors.initials: FP
authors.lastname: Nijkamp
authors.forename: J
authors.initials: J
authors.lastname: van der Laag
authors.forename: H
authors.initials: H
authors.lastname: van Loveren
authors.forename: G T
authors.initials: GT
authors.lastname: Rijkers
authors.forename: W
authors.initials: W
authors.lastname: Kuis
authors.forename: M O
authors.initials: MO
authors.lastname: Hoekstra
mesh_terms: D001500:BCG Vaccine / Q000276:immunology*; D004485:Eczema / Q000209:etiology / Q000276:immunology; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology / Q000276:immunology* / Q000473:pathology; D007223:Infant; D008297:Male; D014611:Vaccination
chemical_list: D001500:BCG Vaccine