Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting
Nicole L Messina, Kaya Gardiner, Susan Donath, Katie Flanagan, Anne-Louise Ponsonby, Frank Shann, Roy Robins-Browne, Bridget Freyne, Veronica Abruzzo, Clare Morison, Lianne Cox, Susie Germano, Christel Zufferey, Petra Zimmermann, Katie J Allen, Peter Vuillermin, Mike South, Dan Casalaz, Nigel Curtis
BMJ Open | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: BCG vaccination reduces all-cause infant mortality in high-mortality settings by more than can be attributed to protection against tuberculosis. This is proposed to result from non-specific protection against non-vaccine targeted ('off-target') infections. There is also evidence that BCG protects against allergic diseases. METHODS AND ANALYSIS: The Melbourne Infant Study: BCG for Allergy and Infection Reduction is a phase III multicentre, single-blinded, randomised controlled trial. A total of 1438 healthy neonates will be randomised to receive either BCG vaccination or no BCG vaccination in the first 10 days of life. Measures of allergy, eczema, infection and asthma will be ob..View full abstract
This study is funded by research grants from the National Health and Medical Research Council (NHMRC) of Australia, The University of Melbourne, RCH Foundation and MCRI.