Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
- Conditions
- EczemaRespiratory Tract InfectionsAllergy
- Interventions
- Biological: BCG
- Registration Number
- NCT01906853
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief Summary
1. 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.
2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1272
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCG BCG Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
- Primary Outcome Measures
Name Time Method Lower respiratory tract infection (LRTI) 0-12 months Measured by parent report
Current asthma 5 years of age Using ISAAC definitions
Atopic sensitisation measured by skin prick test (SPT) 5 years of age Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
Lower respiratory tract infection (LRTI) hospital admissions 0-5 years of age Proportion of participants with ≥1 hospital admission for LRTI reported by parent
Eczema ever 0-5 years of age Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Asthma ever 5 years of age Using ISAAC definitions
- Secondary Outcome Measures
Name Time Method Parent report of food allergy 0-5 years of age Proportion of participants with an allergic reaction to any food reported by parent
Egg sensitisation 5 years of age Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to egg allergen
Diarrhoea Prior to first DTP vaccination Proportion of participants with ≥1 episodes of diarrhoea
Eczema ever 0-5 years of age Proportion of participants with eczema measured by a combined eczema measure
Atopic sensitisation to multiple allergens measured by SPT 5 years of age Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to two or more of a panel of food allergens and aeroallergens
Egg allergy 5 years of age Proportion of participants with a challenge-proven egg allergy OR convincing history of egg allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to egg
Clinical food allergy 5 years of age Proportion of participants with challenge-proven food allergy OR convincing history of food allergy in participants with a SPT wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food allergens
Atopic sensitisation measured by SPT using a more stringent cut-off 5 years of age Proportion of participants with a positive SPT defined as wheal diameter ≥3 mm greater than negative control at 15 min to one or more of a panel of food allergens and aeroallergens
Rate of lower respiratory tract infection (LRTI) 0-5 years of age Number of clinical episodes of LRTI, by parental report
Asthma severity 2-5 years of age Hospital admissions for asthma, by parental report
Rate of upper respiratory tract infection (URTI) Prior to first DTP vaccination Number of clinical episodes of upper respiratory tract infections, by parent report
Rash with fever Prior to first DTP vaccination Proportion of participants with ≥1 episodes of rash with fever
Eczema 0-5 years of age Proportion of clinician-diagnosed eczema, by parental report
Eczema onset 0-5 years of age Age of onset of eczema, by parental report
Eczema severity 0-5 years of age Eczema medication use, by parental report
Atopic wheeze 5 years of age Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens together with parent-reported wheeze
Infections 0-5 years of age Hospital admissions for any infection by parental report
Rate of fever Prior to first DTP vaccination Number of clinical episodes of fever, by parent report
Laboratory measures of the immune response Time Frame: 0-5 years of age Lower respiratory tract infection (LRTI) 0-5 years of age Proportion of participants with ≥1 episode of LRTI, by parental report
Hospitalisation for respiratory tract infection (RTI) 0-5 years of age Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Rate of any infection Prior to first DTP vaccination Number of clinical episodes of where an infant had symptoms of: wheeze, rattle/rattly chest, fever, runny/blocked nose, cough, or diarrhoea (with vomiting), by parent report
Trial Locations
- Locations (2)
Mercy Hospital for Women
🇦🇺Heidelberg, Victoria, Australia
Royal Children's Hospital
🇦🇺Melbourne, Victoria, Australia