University Of Tasmania

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

journal contribution
posted on 2023-05-21, 12:01 authored by Messina, NL, Pittet, LF, Gardiner, K, Freyne, B, Francis, KL, Zufferey, C, Abruzzo, V, Morrison, C, Allen, KJ, Katie FlanaganKatie Flanagan, Ponsonby, AL, Robins-Browne, R, Shann, F, South, M, Vuillermin, P, Donath, S, Casalaz, D, Curtis, N

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.


Publication title

Journal of Infectious Diseases










Tasmanian School of Medicine


Oxford University Press

Place of publication

United States

Rights statement

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

Repository Status

  • Restricted

Socio-economic Objectives

Prevention of human diseases and conditions