Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial Messina, NL, Pittet, LF, Gardiner, K, Freyne, B, Francis, KL, Zufferey, C, Abruzzo, V, Morrison, C, Allen, KJ, Katie L Flanagan, , Ponsonby, AL, Robins-Browne, R, Shann, F, South, M, Vuillermin, Peter, Donath, S, Casalaz, D and Curtis, N 2021, Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial, Journal of Infectious Diseases, vol. 224, no. 7, pp. 1115-1127, doi: 10.1093/infdis/jiab306. Attached Files Name Description MIMEType Size Downloads Title Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial Author(s) Messina, NL Pittet, LF Gardiner, K Freyne, B Francis, KL Zufferey, C Abruzzo, V Morrison, C Allen, KJ Katie L Flanagan, Ponsonby, AL Robins-Browne, R Shann, F South, M Vuillermin, Peter orcid.org/0000-0002-6580-0346 Donath, S Casalaz, D Curtis, N Journal name Journal of Infectious Diseases Volume number 224 Issue number 7 Start page 1115 End page 1127 Total pages 13 Publisher OXFORD UNIV PRESS INC Place of publication United States Publication date 2021-10-01 ISSN 0022-1899 1537-6613 Keyword(s) Science & Technology Life Sciences & Biomedicine Immunology Infectious Diseases Microbiology BCG infant infection off-target nonspecific DIPHTHERIA-TETANUS-PERTUSSIS BCG VACCINATION RESPIRATORY-INFECTION BIRTH MORTALITY INFANTS HOSPITALIZATION CHILDREN RESPONSES Summary Abstract Background Bacille Calmette-Guérin (BCG) vaccination has beneficial off-target effects that may include protecting against non-mycobacterial infectious diseases. We aimed to determine whether neonatal BCG vaccination reduces lower respiratory tract infections (LRTI) in infants in the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) trial. Methods In this investigator-blinded trial, neonates in Australia were randomized to receive BCG-Denmark vaccination or no BCG at birth. Episodes of LRTI were determined by symptoms reported in parent-completed, 3-month questionnaires over the first year of life. Data were analyzed by intention-to-treat using binary regression. Results A total of 1272 neonates were randomized to the BCG vaccination (n = 637) or control (n = 635) group. The proportion of participants with an episode of LRTI in the first year of life among BCG-vaccinated infants was 54.8% compared to 58.0% in the control group, resulting in a risk difference of −3.2 (95% confidence interval, −9.0 to 2.6) after multiple imputation. There was no interaction observed between the primary outcome and sex, maternal BCG, or the other prespecified effect modifiers. Conclusions Based on the findings of this trial, there is insufficient evidence to support the use of neonatal BCG vaccination to prevent LRTI in the first year of life in high-income settings. Language eng DOI 10.1093/infdis/jiab306 Field of Research 06 Biological Sciences 11 Medical and Health Sciences HERDC Research category C1 Refereed article in a scholarly journal Free to Read? Yes Persistent URL http://hdl.handle.net/10536/DRO/DU:30153051 Document type: Journal Article Collections: Faculty of Health School of Medicine Open Access Collection Related Links Link Description Link to full-text (open access)   Connect to published version Go to link with your DU access privileges   Connect to Elements publication management system Go to link with your DU access privileges     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au. Versions Version Filter Type Fri, 02 Jul 2021, 12:54:25 EST Fri, 02 Jul 2021, 12:55:28 EST Sat, 03 Jul 2021, 05:01:33 EST Mon, 05 Jul 2021, 08:06:20 EST Fri, 30 Jul 2021, 06:04:38 EST Tue, 03 Aug 2021, 14:40:08 EST Tue, 03 Aug 2021, 14:42:29 EST Sat, 28 Aug 2021, 14:35:33 EST Sat, 27 Nov 2021, 01:30:19 EST Sat, 27 Nov 2021, 01:46:43 EST Mon, 29 Nov 2021, 12:37:02 EST Fri, 04 Mar 2022, 09:55:25 EST Filtered Full Citation counts:   Cited 1 times in TR Web of Science Cited 1 times in Scopus Search Google Scholar Access Statistics: 86 Abstract Views, 1 File Downloads  -  Detailed Statistics Created: Fri, 02 Jul 2021, 12:55:28 EST