Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1400
Summary
- Conditions
- Allergy
- Eczema
- Respiratory Tract Infections
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 10 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT01906853
- Collaborators
- Royal Children's Hospital
- Mercy Hospital for Women, Australia
- University of Melbourne
- Investigators
- Principal Investigator: Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne