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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

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Messina, NL, Gardiner, K, Donath, S, Flanagan, K, Ponsonby, A-L, Shann, F, Robins-Browne, R, Freyne, B, Abruzzo, V, Morison, C, Cox, L, Germano, S, Zufferey, C, Zimmermann, P, Allen, KJ, Vuillermin, P, South, M, Casalaz, D and Curtis, N 2019 , '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' , BMJ Open, vol. 9, no. 12 , pp. 1-7 , doi: 10.1136/bmjopen-2019-032844.

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Official URL: https://bmjopen.bmj.com/content/9/12/e032844

Abstract

Introduction: BCG vaccination reduces all-cause infantmortality in high-mortality settings by more than canbe attributed to protection against tuberculosis. This isproposed to result from non-specific protection againstnon-vaccine targeted (‘off-target’) infections. There is alsoevidence that BCG protects against allergic diseases.Methods and analysis: The Melbourne Infant Study:BCG for Allergy and Infection Reduction is a phase IIImulticentre, single-blinded, randomised controlled trial.A total of 1438 healthy neonates will be randomised toreceive either BCG vaccination or no BCG vaccinationin the first 10 days of life. Measures of allergy, eczema,infection and asthma will be obtained from parentcompleted questionnaires 3 monthly in the first year and 6monthly from 1 to 5 years of age, and clinical assessmentsat 1 and 5 years of age. Biological samples will also becollected for future immunological studies.Analysis primary outcome: The proportion ofparticipants with measures of allergy and infection (atopicsensitisation, eczema, lower respiratory tract infection)at 1 and 5 years of age, and asthma at 5 years of age.Secondary outcomes: (1) the proportion of participantswith additional measures of allergy, eczema, asthma andinfections; (2) medication use for eczema and asthma; (3)the severity and age of onset of eczema and asthma; (4)the number of episodes of infection; (5) hospitalisationsfor infections and (6) laboratory measures of immuneresponses.Ethics and dissemination: This trial has ethical andgovernance approval from Mercy Health Human ResearchEthics Committee (HREC, No. R12-28) and Royal Children’sHospital HREC (No. 33025) with additional governanceapproval from Barwon Health and St John of God, Geelong,Victoria. Results of this trial will be published in peer-reviewed journals and presented at scientific conferences.

Item Type:	Article
Authors/Creators:	Messina, NL and Gardiner, K and Donath, S and Flanagan, K and Ponsonby, A-L and Shann, F and Robins-Browne, R and Freyne, B and Abruzzo, V and Morison, C and Cox, L and Germano, S and Zufferey, C and Zimmermann, P and Allen, KJ and Vuillermin, P and South, M and Casalaz, D and Curtis, N
Keywords:	allergy, asthma, eczema, immunology, immunsation, infectious diseases, paediatric
Journal or Publication Title:	BMJ Open
Publisher:	BMJ Publishing Group Ltd
ISSN:	2044-6055
DOI / ID Number:	10.1136/bmjopen-2019-032844
Copyright Information:	Copyright 2019 The Authors. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
Item Statistics:	View statistics for this item

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