Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction (MIS BAIR)
- To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life.
- To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants|
- Prevalence of positive skin prick tests [ Time Frame: At 12 months of age ]Allergic disease measured by prevalence of positive skin prick tests (SPT)
- Prevalence of eczema [ Time Frame: 0-12 months of age ]Allergic disease measured by the prevalence of eczema determined by parental report, eczema medication use, medical consultation and an assessment by the research team at 12 months
- Prevalence of lower respiratory tract infections [ Time Frame: 0-12 months of age ]Allergic disease measured by the prevalence of lower respiratory tract infections in the first 12 months of life
- Prevalence and severity of challenge-proven food allergy in study participants with a positive SPT [ Time Frame: At 13 months of age ]
- Prevalence of hospital admissions for respiratory illness [ Time Frame: 12 months ]
- Other measures of infection including febrile episodes [ Time Frame: 0-12 months of age ]
- Laboratory measures of the immune response [ Time Frame: 0-13 months of age ]
- Severity of eczema [ Time Frame: 0-12 months of age ]
- Joint meta-analysis of data [ Time Frame: 36 months ]We plan a joint meta-analysis of our data with the data from the similar Danish study (NCT01694108)
- A sub-group analysis on the effect of presence or absence scar on the non-specific effects of BCG [ Time Frame: 12 months of age ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
No Intervention: No BCG
Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
There has been a dramatic rise in allergic diseases worldwide since the 1980s. Asthma rates increased first, followed by eczema, allergic rhinitis and, more recently, food allergy - especially in infants and young children. In Australia, the prevalence of allergic disease is particularly high: up to 30% of children are affected, and eczema and asthma are among the most common chronic diseases of childhood.
Preventing allergic disease by an immunomodulatory intervention early in life would be a major advance with significant implications for individual health and public health resources. Bacillus Calmette-Guérin (BCG) immunisation is a potential intervention with an established safety profile. This vaccine has powerful non-specific effects on the cellular immune response that potentially prime host immunity away from an allergic pathway. Observational data and one small randomised controlled trial (RCT) suggest that BCG immunisation at birth leads to a substantial reduction in allergic disease - however, there is an absence of level 1 evidence.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906853
|Mercy Hospital for Women|
|Heidelberg, Victoria, Australia, 3084|
|Royal Children's Hospital|
|Melbourne, Victoria, Australia, 3052|
|Principal Investigator:||Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD||Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne|