Lisbeth Marianne Thøstesen1,2, Henrik Fomsgaard Kjaer3, Gitte Thybo Pihl1,2, Thomas Nørrelykke Nissen4, Nina Marie Birk4, Jesper Kjaergaard5, Aksel Karl Georg Jensen6,7, Peter Aaby8, Annette Wind Olesen9, Lone Graff Stensballe10, Dorthe Lisbeth Jeppesen4, Christine Stabell Benn11,12, Poul-Erik Kofoed1,2,12. 1. Department of Pediatrics, Kolding Hospital, Kolding, Denmark. 2. Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark. 3. Allergy Centre and Department of Dermatology, Odense University Hospital, Odense C, Denmark. 4. Department of Pediatrics, 460, Copenhagen University Hospital, Hvidovre, Denmark. 5. Research Unit Women's and Childrens' Health, The Department of Pediatrics and Adolescent Medicine, Juliane Marie Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark. 6. Research Centre for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen S, Denmark. 7. Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark. 8. Bandim Health Project, Statens Serum Institut, Copenhagen S, Denmark. 9. Department of Obstetrics and Gynecology, Odense University Hospital, Odense C, Denmark. 10. The Department of Pediatrics and Adolescent Medicine, Juliane Marie Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark. 11. Research Centre for Vitamins and Vaccines (CVIVA), Statens Serum Institut, Copenhagen S, Denmark. 12. OPEN, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.
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.
RCT Entities:
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.
Authors: Valerie Acm Koeken; L Charlotte J de Bree; Vera P Mourits; Simone Jcfm Moorlag; Jona Walk; Branko Cirovic; Rob Jw Arts; Martin Jaeger; Helga Dijkstra; Heidi Lemmers; Leo Ab Joosten; Christine S Benn; Reinout van Crevel; Mihai G Netea Journal: J Clin Invest Date: 2020-10-01 Impact factor: 14.808
Authors: Laura Raniere Borges Dos Anjos; Adeliane Castro da Costa; Amanda da Rocha Oliveira Cardoso; Rafael Alves Guimarães; Roberta Luiza Rodrigues; Kaio Mota Ribeiro; Kellen Christina Malheiros Borges; Ana Carolina de Oliveira Carvalho; Carla Iré Schnier Dias; Aline de Oliveira Rezende; Carine de Castro Souza; Renato Rodney Mota Ferreira; Guylherme Saraiva; Lilia Cristina de Souza Barbosa; Tayro da Silva Vieira; Marcus Barreto Conte; Marcelo Fouad Rabahi; André Kipnis; Ana Paula Junqueira-Kipnis Journal: Front Immunol Date: 2022-03-22 Impact factor: 7.561
Authors: Samira Imran; Melanie R Neeland; Rebecca Shepherd; Nicole Messina; Kirsten P Perrett; Mihai G Netea; Nigel Curtis; Richard Saffery; Boris Novakovic Journal: iScience Date: 2020-05-17
Authors: Matthias V Kopp; Cathleen Muche-Borowski; Michael Abou-Dakn; Birgit Ahrens; Kirsten Beyer; Katharina Blümchen; Petra Bubel; Adam Chaker; Monika Cremer; Regina Ensenauer; Michael Gerstlauer; Uwe Gieler; Inga-Marie Hübner; Fritz Horak; Ludger Klimek; Berthold V Koletzko; Sybille Koletzko; Susanne Lau; Thomas Lob-Corzilius; Katja Nemat; Eva M J Peters; Antonio Pizzulli; Imke Reese; Claudia Rolinck-Werninghaus; Elien Rouw; Bianca Schaub; Sebastian Schmidt; Jens-Oliver Steiß; Anne Kathrin Striegel; Zsolt Szépfalusi; Dietmar Schlembach; Thomas Spindler; Christian Taube; Valérie Trendelenburg; Regina Treudler; Ulrich Umpfenbach; Christian Vogelberg; Martin Wagenmann; Anke Weißenborn; Thomas Werfel; Margitta Worm; Helmut Sitter; Eckard Hamelmann Journal: Allergol Select Date: 2022-03-04