We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Neonatal Bacille Calmette-Guérin Vaccination and Infections in the First Year of Life: The MIS BAIR Randomized Controlled Trial.
- Authors
Messina, Nicole L; Pittet, Laure F; Gardiner, Kaya; Freyne, Bridget; Francis, Kate L; Zufferey, Christel; Abruzzo, Veronica; Morrison, Clare; Allen, Katrina J; Flanagan, Katie L; Ponsonby, Anne-Louise; Robins-Browne, Roy; Shann, Frank; South, Mike; Vuillermin, Peter; Donath, Susan; Casalaz, Dan; Curtis, Nigel
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
DENMARK; AUSTRALIA; BCG vaccines; RESPIRATORY infections; VACCINATION; INFANTS; COMMUNICABLE diseases
- Publication
Journal of Infectious Diseases, 2021, Vol 224, Issue 7, p1115
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiab306