Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Dec 15;9(12):e032844.
doi: 10.1136/bmjopen-2019-032844.

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  1   2 , Kaya Gardiner  1 , Susan Donath  2   3 , Katie Flanagan  4   5 , Anne-Louise Ponsonby  2   6 , Frank Shann  2   7 , Roy Robins-Browne  1   8 , Bridget Freyne  1   2 , Veronica Abruzzo  1 , Clare Morison  1 , Lianne Cox  1   2 , Susie Germano  1 , Christel Zufferey  1 , Petra Zimmermann  1   2 , Katie J Allen  9 , Peter Vuillermin  10   11 , Mike South  2   12 , Dan Casalaz  13 , Nigel Curtis  14   2   15
Affiliations

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 et al. BMJ Open. .

Abstract

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 obtained from parent-completed questionnaires 3 monthly in the first year and 6 monthly from 1 to 5 years of age, and clinical assessments at 1 and 5 years of age. Biological samples will also be collected for future immunological studies.

Analysis primary outcome: The proportion of participants with measures of allergy and infection (atopic sensitisation, 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 participants with additional measures of allergy, eczema, asthma and infections; (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) hospitalisations for infections and (6) laboratory measures of immune responses.

Ethics and dissemination: This trial has ethical and governance approval from Mercy Health Human Research Ethics Committee (HREC, No. R12-28) and Royal Children's Hospital HREC (No. 33025) with additional governance approval 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.

Trial registration number: NCT01906853.

Keywords: allergy; asthma; eczema; immunology; immunsation; infectious diseases; paediatric.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

References

    1. World Health Organization Immunization coverage estimates by who region: BCG, 2018. http://apps.who.int/gho/data/view.main.81500?lang=en
    1. Higgins JPT, Soares-Weiser K, López-López JA, et al. . Association of BCG, DTP, and measles containing vaccines with childhood mortality: systematic review. BMJ 2016;355 10.1136/bmj.i5170 - DOI - PMC - PubMed
    1. Pollard AJ, Finn A, Curtis N. Non-Specific effects of vaccines: plausible and potentially important, but implications uncertain. Arch Dis Child 2017;102:1077–81. 10.1136/archdischild-2015-310282 - DOI - PubMed
    1. Biering-Sorensen S, Aaby P, Lund N, et al. . Early BCG-Denmark and neonatal mortality among infants weighing. Clin Infect Dis 2017;65:1183–90. - PMC - PubMed
    1. Aaby P, Roth A, Ravn H, et al. . Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis 2011;204:245–52. 10.1093/infdis/jir240 - DOI - PubMed

Publication types

Associated data