The Melbourne Infant Study – BCG for Allergy and Infection Reduction (MIS BAIR)

The Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) study is a randomised controlled trial (RCT) to assess the effect of neonatal BCG (tuberculosis) vaccination on clinical allergy and infection outcomes over the first five years of life. The study is based on the hypothesis that the heterologous effects of BCG on innate immunity and the cellular immune response has a beneficial effect on the developing immune system. The study has both clinical and laboratory components.

The clinical outcome measures are respiratory infections, asthma, eczema and allergic sensitisation (measured by skin prick test). A combination of medical records and parent-completed online questionnaires are used to collect extensive and detailed antenatal, perinatal and postnatal data. The laboratory component comprises an extensive collection of biosamples for future immunological and molecular studies.

Year 2013-2016 2013-2016 2013-2016 2013-2016 2013-2016 2014-2017 2014-2017 2014-2018 2018 2015-2018 2015-2018 2016-2019 2016-2019 2017-2020 2017-2020 2018-2021 2018-2021 2021 2020 2021 2022 2022 2022 2022 2022 2022
Phase Recruitment (pre-birth) Randomisation/birth Discharge from hospital 7 days post randomisation 3 months 6 months 9 months 12 months End Part 1 18 months 24 months 30 months 36 months 42 months 48 months 54 months 60 months End Part 2 COVID Immune: Baseline COVID Immune: 12mth follow-up COSI BAIR: Visit 1 COSI BAIR: Visit 1 +7 days COSI BAIR: Visit 2 COSI BAIR: Visit 2 + 7 days COSI BAIR: Visit 2 + 28 days COSI BAIR: Visit 2 + 182 days
Age Pre-birth Birth Birth Early infancy 3 months 6 months 9 months 12 months End Part 1 18 months 24 months 30 months 36 months 42 months 48 months 54 months 60 months End Part 2 5-6 years End COVID Immune 5-11 years 5-11 years 5-11 years 5-11 years 5-11 years End COSIBAIR
N 1272 Total 637 BCG 635 no BCG Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Complete Substudy: 50 Complete Complete Complete Complete Complete
RELEVANT LIFECOURSE DOMAINS Allergies Allergies Allergies
Anthropometrics Anthropometrics Anthropometrics
Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics
Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples
Cardiovascular health
Demographics Demographics Demographics Demographics
Education and childcare Education and childcare Education and childcare Education and childcare
Environmental exposures Environmental exposures Environmental exposures Environmental exposures
Family environment Family environment
Health services Health services Health services Health services Health services
Imaging Imaging Imaging Imaging Imaging
Medications and supplements Medications and supplements Medications and supplements
Mental health and behaviour problems
Methodology Methodology Methodology Methodology
Nutrition Nutrition Nutrition
Other health information Other health information Other health information Other health information Other health information
Peer relationships
Physical appearance Physical appearance Physical appearance Physical appearance
Pregnancy and birth
Psychosocial wellbeing
Puberty
Respiratory health Respiratory health Respiratory health
Romantic relationships
Sleep Sleep
Substance use Substance use Substance use
Study Summary
Study name Melbourne Infant Study: BCG for Allergy and Infection Reduction
Study abbreviation MIS BAIR
Current principal investigator/s Nigel Curtis
Current project manager

Casey Goodall
Primary Institution/s Murdoch Children’s Research Institute - MCRI
Collaborating Institution/s The University of Melbourne - UoM
The Royal Children’s Hospital - RCH
Mercy Health
Barwon Health
Major funding source/s National Health and Medical Research Council - NHMRC
Murdoch Children’s Research Institute - MCRI
The Royal Children’s Hospital Foundation - RCHF
University of Melbourne
Study website https://www.mcri.edu.au/research/projects/misbair
Study focus

To assess the effect of neonatal BCG (tuberculosis) vaccination on clinical allergy and infection outcomes over the first five years of life, together with the collection of serial blood and stool samples for immunological and other laboratory studies.
Sampling frame

Pregnant women attending participating antenatal clinics in Melbourne and Geelong were approached to participate (Mercy Hospital for Women, Melbourne; Werribee Mercy Hospital; University Hospital Geelong; St John of God Geelong Hospital). Media releases were also used to inform pregnant women about the study. Pregnant women or mothers interested in joining the study, but not being cared for at a study maternity site, were enrolled through the Murdoch Children’s Research Institute, Melbourne.
Eligible infants were: less than 10 days old, birth weight > 1500 g, born no earlier than 8 weeks before estimated date of delivery, had no contraindication to BCG administration and no requirement for BCG vaccination in the first year of life.
Primary study type Randomised Control Trial / Other trial
Year commenced

2013
Is this study ongoing? Yes - the study is ongoing
Ongoing recruitment? No
Sample size (N)

Total: 1272; 637 cases, 635 controls
Survey data available? Yes
Imaging data available? Yes
Linkage to administrative dataset/s? No, no consent to link to administrative dataset(s) obtained
Biosamples available? Yes
Are data available to others outside study team, with appropriate safeguards and structures in line with the cohort’s ethics and governance processes? Yes
Are there any costs associated with data/sample access for approved requests? There may be costs associated with access, evaluated on a case by case basis
Broadest type of participant consent available Extended consent (can be used for future ethically approved research related to this project)

2021

Pittet LF, Messina NL, Gardiner K, Orsini F, Abruzzo V, Bannister S, Bonten M, Campbell JL, Croda J, Dalcolmo M, Elia S, Germano S, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann TR, Guimarães Lacerda MV, Lee KJ, Legge D, Lucas M, Lynn DJ, McDonald E, Manning L, Munns CF, Perrett KP, Prat Aymerich C, Richmond P, Shann F, Sudbury E, Villanueva P, Wood NJ, Lieschke K, Subbarao K, Davidson A, Curtis N, BRACE trial Consortium Group . (2021). BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open, 11(10), e052101. DOI: 10.1136/bmjopen-2021-052101

Study Contacts
Principal investigator/s Nigel Curtis
Project manager

Casey Goodall
Study Contact

Ph: +61 427 871 863
Email: misbair@mcri.edu.au
Address: MIS BAIR Study
Infectious Diseases and Microbiology
Murdoch Children's Research Institute,
Royal Children’s Hospital
Flemington Road, Parkville
Victoria 3052 Australia