TY - JOUR
T1 - Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months
AU - Thøstesen, Lisbeth Marianne
AU - Kjaer, Henrik Fomsgaard
AU - Pihl, Gitte Thybo
AU - Nissen, Thomas Nørrelykke
AU - Birk, Nina Marie
AU - Kjaergaard, Jesper
AU - Jensen, Aksel Karl Georg
AU - Aaby, Peter
AU - Olesen, Annette Wind
AU - Stensballe, Lone Graff
AU - Jeppesen, Dorthe Lisbeth
AU - Benn, Christine Stabell
AU - Kofoed, Poul-Erik
N1 - This article is protected by copyright. All rights reserved.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - BACKGROUND: Vaccination with Bacillus Calmette-Guérin (BCG) is used in many countries as protection against tuberculosis. Studies have suggested that BCG may also have non-specific effects, reducing non-tuberculosis mortality, morbidity, and atopic manifestations. In this study we evaluated the effect of neonatal BCG vaccination on allergic sensitization and suspected food allergy at 13 months of age.METHODS: The Danish Calmette Study was conducted from 2012-2015 at three Danish hospitals. Within 7 days of birth, the 4262 newborns of 4184 included mothers were randomized 1:1 to BCG or to a no-intervention control group. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency, or no Danish-speaking parent. Follow-up information was collected through telephone interviews at 3 and 13 months of age. Subgroups of participants were offered blood sampling at 13 months of age.RESULTS: By 13 months of age the parents and/or general practitioners of 5.6% (117/2089) of the children in the BCG group and 6.1% (126/2061) of the control group suspected food allergy, resulting in a risk ratio comparing BCG-vaccinated children with control children of 0.91 (95% CI 0.71 to 1.16). Among 1370 blood samples, sensitization (Phadiatop Infant > 0.35 kUA/l) was found in 55/743 (7.4%) children in the BCG group and 50/627 (8.0%) of the control group (risk ratio 0.94 (0.65 to 1.36)).CONCLUSION: In this randomized clinical trial neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age. This article is protected by copyright. All rights reserved.
AB - BACKGROUND: Vaccination with Bacillus Calmette-Guérin (BCG) is used in many countries as protection against tuberculosis. Studies have suggested that BCG may also have non-specific effects, reducing non-tuberculosis mortality, morbidity, and atopic manifestations. In this study we evaluated the effect of neonatal BCG vaccination on allergic sensitization and suspected food allergy at 13 months of age.METHODS: The Danish Calmette Study was conducted from 2012-2015 at three Danish hospitals. Within 7 days of birth, the 4262 newborns of 4184 included mothers were randomized 1:1 to BCG or to a no-intervention control group. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency, or no Danish-speaking parent. Follow-up information was collected through telephone interviews at 3 and 13 months of age. Subgroups of participants were offered blood sampling at 13 months of age.RESULTS: By 13 months of age the parents and/or general practitioners of 5.6% (117/2089) of the children in the BCG group and 6.1% (126/2061) of the control group suspected food allergy, resulting in a risk ratio comparing BCG-vaccinated children with control children of 0.91 (95% CI 0.71 to 1.16). Among 1370 blood samples, sensitization (Phadiatop Infant > 0.35 kUA/l) was found in 55/743 (7.4%) children in the BCG group and 50/627 (8.0%) of the control group (risk ratio 0.94 (0.65 to 1.36)).CONCLUSION: In this randomized clinical trial neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age. This article is protected by copyright. All rights reserved.
KW - Journal Article
U2 - 10.1111/pai.12748
DO - 10.1111/pai.12748
M3 - Journal article
C2 - 28660649
SN - 0905-6157
VL - 28
SP - 588
EP - 596
JO - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
JF - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
IS - 6
ER -