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.



Scroll horizontally to view all phases

Trial 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
5-6 years
COVID Immune
6-7 years
COVID Immune
Year 2013-2016 2013-2016 2013-2016 2013-2016 2013-2016 2014-2017 2014-2017 2014-2018 2015-2018 2015-2018 2016-2019 2016-2019 2017-2020 2017-2020 2018-2021 2018-2021 2020: Baseline 2021: 12 mth follow-up
Identifiers and miscellaneous Identifiers and miscellaneous Identifiers and miscellaneous
Allergies Allergies Allergies
Anthropometrics Anthropometrics Anthropometrics
Behavioural problems
Birth
Demographics Demographics Demographics Demographics
Education and childcare Education and childcare Education and childcare Education and childcare
Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens)
General health General health General health
Imaging Imaging
Medications and supplements Medications and supplements Medications and supplements
Mental health
Nutrition Nutrition
Physical characteristics Physical characteristics Physical characteristics Physical characteristics
Relationships
Reproductive health and pregnancy
Resilience and wellbeing
Respiratory health Respiratory health Respiratory health
Substance use Substance use Substance use Substance use
Trial specific information
Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples Biosamples
Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics
Study Summary
Study name Melbourne Infant Study: BCG for Allergy and Infection Reduction
Study abbreviation MIS BAIR
Current principal investigator/s Professor Nigel Curtis
Current project manager Christine Axelrad
Primary Institution Murdoch Children’s Research Institute
Collaborating Institution/s University of Melbourne
Royal Children’s Hospital
Mercy Health
Barwon Health
Major funding sources National Health and Medical Research Council
Murdoch Children’s Research Institute
Royal Children’s Hospital Foundation
University of Melbourne
Study website http://misbair.org.au/
Are data available to others outside study team? Yes, with approval from Professor Nigel Curtis and RCH ethics.
Study focus (e.g. social development) MIS BAIR is an open randomised controlled trial (RCT) that will assess the effect of neonatal BCG vaccination on clinical allergy and infection outcomes in infants in Melbourne (Australia).
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.

Study type (e.g. randomised control trial, cohort, case-control) Randomised controlled trial
Year commenced 2013
Ongoing recruitment? No
Commencement sample (N) 637 BCG
635 no BCG
(1272 Total)
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? Response to BCG vaccination (photo of scar/scar size)
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? No
Biosamples (e.g. buccal, blood, hair)? Venous blood
Faeces
Respiratory samples for viral and microbiome analyses
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)?  Future research related to this project (BCG, allergy, child health or infections) (Extended consent).
Year Age (mean, range) Eligible sample (not deceased, not withdrawn)
2013-2016 Recruitment (pre-birth) 637 BCG
635 no BCG
(1272 Total)
2013-2016 Randomisation (birth) Complete
2013-2016 Discharge (from hospital) Complete
2013-2016 7 days post randomisation Complete
2013-2016 3 months Complete
2014-2017 6 months Complete
2014-2017 9 months Complete
2014-2018 12 months (end of part 1) Complete
2015-2018 18 months Complete
2015-2018 24 months Complete
2016-2019 30 months Ongoing
2016-2019 36 months Ongoing
2017-2020 42 months Ongoing
2017-2020 48 months Ongoing
2018-2021 54 months Ongoing
2018-2021 60 months (end of part 2) Ongoing

Principal Investigator

Professor Nigel Curtis

Project Manager

Christine Axelrad

Study Contact

Ph: +61 427 871 863
Email: misbair@mcri.edu.au

Postal Address

MIS BAIR Study
Infectious Diseases and Microbiology
Murdoch Children’s Research Institute
Royal Children’s Hospital
50 Flemington Rd
Parkville VIC 3052
Australia