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Title: | Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial. | Austin Authors: | Messina, Nicole L;Gardiner, Kaya;Pittet, Laure F;Forbes, Emily K;Francis, Kate L;Freyne, Bridget;Zufferey, Christel;Abruzzo, Veronica;Morison, Clare;Turner, Hannah;Allen, Katrina J;Flanagan, Katie L;Ponsonby, Anne-Louise;Robins-Browne, Roy;Shann, Frank;Vuillermin, Peter;Donath, Susan;Casalaz, Dan;Curtis, Nigel | Affiliation: | Infectious Diseases, Clinical Epidemiology & Biostatistics Unit, Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.;Department of Paediatrics, Department of Microbiology & Immunology, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, Victoria, Australia. Infectious Diseases, Clinical Epidemiology & Biostatistics Unit, Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia. School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.;Tasmanian Vaccine Trial Centre, Clifford Craig Foundation, Launceston General Hospital, Launceston, Tasmania, Australia.;School of Health and Biomedical Science, RMIT University, Melbourne, Victoria, Australia. The Florey Institute of Neuroscience and Mental Health Infectious Diseases, Clinical Epidemiology & Biostatistics Unit, Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.;Department of Paediatrics, Department of Microbiology & Immunology, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, Victoria, Australia. Neonatal Intensive Care Unit, Mercy Hospital for Women, Heidelberg, Victoria, Australia. Infectious Diseases, Clinical Epidemiology & Biostatistics Unit, Population Allergy, Murdoch Children's Research Institute, Parkville, Victoria, Australia.;Department of Paediatrics, Department of Microbiology & Immunology, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, Victoria, Australia.;Department of General Medicine, Department of Research Operations, Infectious Diseases Unit, The Royal Children's Hospital, Parkville, Victoria, Australia. |
Issue Date: | Sep-2024 | Date: | 2024 | Publication information: | Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology 2024-09; 54(9) | Abstract: | The beneficial off-target effects of Bacille Calmette-Guérin (BCG) vaccination potentially include protection against allergy. In the MIS BAIR trial, we aimed to determine whether neonatal BCG vaccination reduces atopic sensitisation and clinical food allergy in infants. In this randomised controlled trial, 1272 neonates were allocated to BCG-Denmark vaccine (0.05 mL intradermal dose) or no BCG at birth. Randomisation was stratified by recruitment site, mode of delivery and plurality of birth. The primary outcome was the incidence of atopic sensitisation determined by skin prick test at 1 year of age. Food allergy was determined by 3-monthly online questionnaires and oral food challenges. Data were analysed by intention-to-treat using binary regression. gov (NCT01906853). Atopic sensitisation during the first year of life was 22.9% among infants in the BCG group and 18.9% in the control group (adjusted risk difference (aRD) 3.8% (95% CI -1.5 to 9.1) after multiple imputation). Clinical food allergy was similar between infants in the BCG and control groups (9.8% vs. 9.6%; aRD 0.2, 95% CI -3.4 to 3.8). An interaction was observed between the primary outcome and maternal history of BCG vaccination. No interaction was observed for the additional prespecified potential effect modifiers tested (sex, delivery mode, family history of any allergy, season of birth, hepatitis B vaccination at randomisation, BCG scar and age at BCG administration). Neonatal BCG-Denmark vaccination does not protect against atopic sensitisation or clinical food allergy in the first year of life. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/35430 | DOI: | 10.1111/cea.14537 | ORCID: | 0000-0001-8404-4462 0000-0001-9796-4567 0000-0002-2395-4574 0000-0002-1751-5313 0000-0002-6581-3657 0000-0002-9899-1804 0000-0002-6580-0346 0000-0003-3446-4594 |
Journal: | Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology | PubMed URL: | 39004434 | ISSN: | 1365-2222 | Type: | Journal Article | Subjects: | BCG atopic sensitisation food allergy food challenge vaccine off‐target effects |
Appears in Collections: | Journal articles |
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