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Neonatal Bacille Calmette-Guerin caccination and infections in the first year of life: The MIS BAIR randomized controlled trial


Messina, NL and Pittet, LF and Gardiner, K and Freyne, B and Francis, KL and Zufferey, C and Abruzzo, V and Morrison, C and Allen, KJ and Flanagan, KL and Ponsonby, AL and Robins-Browne, R and Shann, F and South, M and Vuillermin, P and Donath, S and Casalaz, D and Curtis, N, Neonatal Bacille Calmette-Guerin caccination and infections in the first year of life: The MIS BAIR randomized controlled trial, Journal of Infectious Diseases, 224, (7) pp. 1115-1127. ISSN 0022-1899 (2021) [Refereed Article]

Copyright Statement

The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.

DOI: doi:10.1093/infdis/jiab306


Background: Bacille Calmette-Guerin (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.

Item Details

Item Type:Refereed Article
Keywords:BCG; infant; infection; nonspecific; off-target
Research Division:Biomedical and Clinical Sciences
Research Group:Paediatrics
Research Field:Infant and child health
Objective Division:Health
Objective Group:Clinical health
Objective Field:Prevention of human diseases and conditions
UTAS Author:Flanagan, KL (Dr Katie Flanagan)
ID Code:152385
Year Published:2021
Web of Science® Times Cited:2
Deposited By:Health Sciences
Deposited On:2022-08-18
Last Modified:2022-09-15

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