Neonatal BCG vaccination and atopic dermatitis before 13 months of age: A randomized clinical trial

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Background: Studies have suggested that Bacillus Calmette-Guérin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis. Methods: The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth new-borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months. Results: Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR = 0.90 [95% confidence intervals 0.80-1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74-0.95)) and children without atopic predisposition (RR 1.09 [0.88-1.37]) (test of no interaction, P =.04). Conclusion: Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12-76).

OriginalsprogEngelsk
TidsskriftAllergy: European Journal of Allergy and Clinical Immunology
Vol/bind73
Udgave nummer2
Sider (fra-til)498-504
ISSN0105-4538
DOI
StatusUdgivet - feb. 2018

Fingeraftryk

Atopic Dermatitis
Randomized Controlled Trials
Numbers Needed To Treat
Gestational Age
Confidence Intervals
Interviews
Control Groups

Citer dette

Thøstesen, Lisbeth Marianne ; Kjaergaard, Jesper ; Pihl, Gitte Thybo ; Birk, Nina Marie ; Nissen, Thomas Nørrelykke ; Aaby, Peter ; Jensen, Aksel Karl Georg ; Olesen, Annette Wind ; Stensballe, Lone Graff ; Jeppesen, Dorthe Lisbeth ; Benn, Christine Stabell ; Kofoed, Poul-Erik. / Neonatal BCG vaccination and atopic dermatitis before 13 months of age : A randomized clinical trial. I: Allergy: European Journal of Allergy and Clinical Immunology. 2018 ; Bind 73, Nr. 2. s. 498-504.
@article{e588d87f26cc4c34a2ed69f48ca64feb,
title = "Neonatal BCG vaccination and atopic dermatitis before 13 months of age: A randomized clinical trial",
abstract = "Background: Studies have suggested that Bacillus Calmette-Gu{\'e}rin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis. Methods: The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth new-borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months. Results: Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7{\%}) children in the BCG group and 495/1,952 (25.4{\%}) children in the control group (RR = 0.90 [95{\%} confidence intervals 0.80-1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74-0.95)) and children without atopic predisposition (RR 1.09 [0.88-1.37]) (test of no interaction, P =.04). Conclusion: Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12-76).",
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author = "Th{\o}stesen, {Lisbeth Marianne} and Jesper Kjaergaard and Pihl, {Gitte Thybo} and Birk, {Nina Marie} and Nissen, {Thomas N{\o}rrelykke} and Peter Aaby and Jensen, {Aksel Karl Georg} and Olesen, {Annette Wind} and Stensballe, {Lone Graff} and Jeppesen, {Dorthe Lisbeth} and Benn, {Christine Stabell} and Poul-Erik Kofoed",
note = "This article is protected by copyright. All rights reserved.",
year = "2018",
month = "2",
doi = "10.1111/all.13314",
language = "English",
volume = "73",
pages = "498--504",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
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Thøstesen, LM, Kjaergaard, J, Pihl, GT, Birk, NM, Nissen, TN, Aaby, P, Jensen, AKG, Olesen, AW, Stensballe, LG, Jeppesen, DL, Benn, CS & Kofoed, P-E 2018, 'Neonatal BCG vaccination and atopic dermatitis before 13 months of age: A randomized clinical trial', Allergy: European Journal of Allergy and Clinical Immunology, bind 73, nr. 2, s. 498-504. https://doi.org/10.1111/all.13314

Neonatal BCG vaccination and atopic dermatitis before 13 months of age : A randomized clinical trial. / Thøstesen, Lisbeth Marianne; Kjaergaard, Jesper; Pihl, Gitte Thybo; Birk, Nina Marie; Nissen, Thomas Nørrelykke; Aaby, Peter; Jensen, Aksel Karl Georg; Olesen, Annette Wind; Stensballe, Lone Graff; Jeppesen, Dorthe Lisbeth; Benn, Christine Stabell; Kofoed, Poul-Erik.

I: Allergy: European Journal of Allergy and Clinical Immunology, Bind 73, Nr. 2, 02.2018, s. 498-504.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Neonatal BCG vaccination and atopic dermatitis before 13 months of age

T2 - A randomized clinical trial

AU - Thøstesen, Lisbeth Marianne

AU - Kjaergaard, Jesper

AU - Pihl, Gitte Thybo

AU - Birk, Nina Marie

AU - Nissen, Thomas Nørrelykke

AU - Aaby, Peter

AU - Jensen, Aksel Karl Georg

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 - 2018/2

Y1 - 2018/2

N2 - Background: Studies have suggested that Bacillus Calmette-Guérin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis. Methods: The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth new-borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months. Results: Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR = 0.90 [95% confidence intervals 0.80-1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74-0.95)) and children without atopic predisposition (RR 1.09 [0.88-1.37]) (test of no interaction, P =.04). Conclusion: Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12-76).

AB - Background: Studies have suggested that Bacillus Calmette-Guérin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis. Methods: The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth new-borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months. Results: Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR = 0.90 [95% confidence intervals 0.80-1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74-0.95)) and children without atopic predisposition (RR 1.09 [0.88-1.37]) (test of no interaction, P =.04). Conclusion: Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12-76).

KW - Journal Article

KW - Bacillus Calmette-Guérin

KW - infants

KW - atopic dermatitis

KW - heterologous immunity

KW - randomized controlled trial

KW - Humans

KW - Infant

KW - Male

KW - BCG Vaccine/therapeutic use

KW - Female

KW - Dermatitis, Atopic/epidemiology

KW - Netherlands/epidemiology

KW - Infant, Newborn

U2 - 10.1111/all.13314

DO - 10.1111/all.13314

M3 - Journal article

C2 - 28929567

VL - 73

SP - 498

EP - 504

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

SN - 0105-4538

IS - 2

ER -