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.
Study Summary | |
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Study name | Melbourne Infant Study: BCG for Allergy and Infection Reduction |
Study abbreviation | MIS BAIR |
Current principal investigator/s |
Nigel Curtis |
Current project manager |
Christine Axelrad |
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 | http://misbair.org.au/ |
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. |
Primary study type | Randomised Control Trial / Other trial |
Primary participant (at recruitment) | Index child |
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 are usually no costs associated with access |
Broadest type of participant consent available |
Extended consent (can be used for future ethically approved research related to this project) |
Phase | Year | Age | Sample size (N) |
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Recruitment (pre-birth) | 2013-2016 | Pre-birth | 1272 Total 637 BCG 635 no BCG |
Randomisation/birth | 2013-2016 | Birth | Complete |
Discharge from hospital | 2013-2016 | Birth | Complete |
7 days post randomisation | 2013-2016 | Early infancy | Complete |
3 months | 2013-2016 | 3 months | Complete |
6 months | 2014-2017 | 6 months | Complete |
9 months | 2014-2017 | 9 months | Complete |
12 months | 2014-2018 | 12 months | Complete |
End Part 1 | 2018 | End Part 1 | Complete |
18 months | 2015-2018 | 18 months | Complete |
24 months | 2015-2018 | 24 months | Complete |
30 months | 2016-2019 | 30 months | Ongoing |
36 months | 2016-2019 | 36 months | Ongoing |
42 months | 2017-2020 | 42 months | Ongoing |
48 months | 2017-2020 | 48 months | Ongoing |
54 months | 2018-Ongoing | 54 months | IN PROGRESS |
60 months | 2018-Ongoing | 60 months | IN PROGRESS |
End Part 2 | 2021-Ongoing | End Part 2 | IN PROGRESS |
COVID Immune: Baseline | 2020 | 5-6 years | Ongoing |
COVID Immune: 12mth follow-up | 2021-Ongoing | 6-7 years | IN PROGRESS |
Study Contacts | |
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Principal investigator/s |
Nigel Curtis |
Project manager |
Christine Axelrad |
Study Contact |
Ph: +61 427 871 863 |