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, 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.



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 Kaya Gardiner
Primary Institution Murdoch Childrens 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 Childrens 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 Royal Children’s Hospital, Melbourne. Eligible infants were: less than 10 days old, birth weight > 1500 g, and born no earlier than 8 weeks before estimated date of delivery.
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) Ongoing
2013-2016 Discharge (from hospital) Ongoing
2013-2016 7 days post randomisation Ongoing
2013-2016 3 months Ongoing
2014-2017 6 months Ongoing
2014-2017 9 months Ongoing
2014-2018 12 months (end of part 1) Ongoing
2015-2018 18 months Ongoing
2015-2018 24 months Ongoing
2016-2019 30 months Ongoing
2016-2019 36 months Ongoing
2017-2020 42 months Planned
2017-2020 48 months Planned
2018-2021 54 months Planned
2018-2021 60 months (end of part 2) Planned

Principal Investigator

Professor Nigel Curtis

Project Manager

Kaya Gardiner

Study Contact

Ph: +613 9936 6042
Email: misbair@mcri.edu.au

Postal Address

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