Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months

Lisbeth Marianne Thøstesen; Henrik Fomsgaard Kjaer; Gitte Thybo Pihl; Thomas Nørrelykke Nissen; Nina Marie Birk; Jesper Kjaergaard; Aksel Karl Georg Jensen; Peter Aaby; Annette Wind Olesen; Lone Graff Stensballe; Dorthe Lisbeth Jeppesen; Christine Stabell Benn; Poul-Erik Kofoed

doi:10.1111/pai.12748

Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months

Lisbeth Marianne Thøstesen, Henrik Fomsgaard Kjaer, Gitte Thybo Pihl, Thomas Nørrelykke Nissen, Nina Marie Birk, Jesper Kjaergaard, Aksel Karl Georg Jensen, Peter Aaby, Annette Wind Olesen, Lone Graff Stensballe, Dorthe Lisbeth Jeppesen, Christine Stabell Benn, Poul-Erik Kofoed

15 Citations (Scopus)

Abstract

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 to 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 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]). Conclusion: In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.

Original language	English
Journal	Pediatric Allergy and Immunology
Volume	28
Issue number	6
Pages (from-to)	588-596
Number of pages	9
ISSN	0905-6157
DOIs	https://doi.org/10.1111/pai.12748
Publication status	Published - Sept 2017

Keywords

Journal Article

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/pai.12748

Cite this

Thøstesen, L. M., Kjaer, H. F., Pihl, G. T., Nissen, T. N., Birk, N. M., Kjaergaard, J., Jensen, A. K. G., Aaby, P., Olesen, A. W., Stensballe, L. G., Jeppesen, D. L., Benn, C. S., & Kofoed, P.-E. (2017). Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months. Pediatric Allergy and Immunology, 28(6), 588-596. https://doi.org/10.1111/pai.12748

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title = "Neonatal BCG has no effect on allergic sensitization and suspected food allergy until 13 months",

abstract = "Background: Vaccination with Bacillus Calmette-Gu{\'e}rin (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 to 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 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]). Conclusion: In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.",

keywords = "Journal Article",

author = "Th{\o}stesen, {Lisbeth Marianne} and Kjaer, {Henrik Fomsgaard} and Pihl, {Gitte Thybo} and Nissen, {Thomas N{\o}rrelykke} and Birk, {Nina Marie} and Jesper Kjaergaard and Jensen, {Aksel Karl Georg} and Peter Aaby and Olesen, {Annette Wind} and Stensballe, {Lone Graff} and Jeppesen, {Dorthe Lisbeth} and Benn, {Christine Stabell} and Poul-Erik Kofoed",

note = "{\textcopyright} 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.",

year = "2017",

month = sep,

doi = "10.1111/pai.12748",

language = "English",

volume = "28",

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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

PY - 2017/9

Y1 - 2017/9

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 to 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 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]). Conclusion: In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.

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 to 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 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]). Conclusion: In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.

KW - Journal Article

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DO - 10.1111/pai.12748

M3 - Journal article

C2 - 28660649

SN - 0905-6157

VL - 28

SP - 588

EP - 596

JO - Pediatric Allergy and Immunology

JF - Pediatric Allergy and Immunology

IS - 6