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Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial

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journal contribution
posted on 2021-10-01, 00:00 authored by N L Messina, L F Pittet, K Gardiner, B Freyne, K L Francis, C Zufferey, V Abruzzo, C Morrison, K J Allen, Katie L Flanagan, A L Ponsonby, R Robins-Browne, F Shann, M South, Peter VuillerminPeter Vuillermin, S Donath, D Casalaz, N Curtis
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.

History

Journal

Journal of Infectious Diseases

Volume

224

Issue

7

Pagination

1115 - 1127

Publisher

OXFORD UNIV PRESS INC

Location

United States

ISSN

0022-1899

eISSN

1537-6613

Language

English

Publication classification

C1 Refereed article in a scholarly journal