Bacille-Calmette-Guerin vaccination and the development of allergic disease in children: a randomized, prospective, single-blind study.
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.
Steenhuis
T J
TJ
Department of General Paediatrics, Wilhelmina's Children's Hospital, University Hospital Utrecht, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands.
van Aalderen
W M C
WM
Bloksma
N
N
Nijkamp
F P
FP
van der Laag
J
J
van Loveren
H
H
Rijkers
G T
GT
Kuis
W
W
Hoekstra
M O
MO
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
D001500:BCG Vaccine