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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,272
Mercy Hospital for Women
Heidelberg, Victoria, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
Atopic sensitisation measured by skin prick test (SPT)
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
Time frame: 1 year of age
Atopic sensitisation measured by skin prick test (SPT)
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
Time frame: 5 years of age
Lower respiratory tract infection (LRTI)
Measured by parent report
Time frame: 0-12 months
Lower respiratory tract infection (LRTI) hospital admissions
Proportion of participants with ≥1 hospital admission for LRTI reported by parent
Time frame: 0-5 years of age
Eczema ever
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Time frame: 0-12 months
Eczema ever
Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
Time frame: 0-5 years of age
Current asthma
Using ISAAC definitions
Time frame: 5 years of age
Asthma ever
Using ISAAC definitions
Time frame: 5 years of age
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Clinical food allergy
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
Time frame: 1 year of age
Clinical food allergy
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
Time frame: 5 years of age
Atopic sensitisation measured by SPT using a more stringent cut-off
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
Time frame: 1 year of age
Atopic sensitisation measured by SPT using a more stringent cut-off
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
Time frame: 5 years of age
Atopic sensitisation to multiple allergens measured by SPT
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
Time frame: 1 year of age
Atopic sensitisation to multiple allergens measured by SPT
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
Time frame: 5 years of age
Parent report of food allergy
Proportion of participants with an allergic reaction to any food reported by parent
Time frame: 0-12 months of age
Parent report of food allergy
Proportion of participants with an allergic reaction to any food reported by parent
Time frame: 0-5 years of age
Egg sensitisation
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to egg allergen
Time frame: 1 year of age
Egg sensitisation
Proportion of participants with a positive SPT defined as wheal diameter ≥2 mm greater than negative control at 15 min to egg allergen
Time frame: 5 years of age
Egg allergy
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
Time frame: 1 year of age
Egg allergy
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
Time frame: 5 years of age
Atopic wheeze
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
Time frame: 1 year of age
Atopic wheeze
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
Time frame: 5 years of age
Lower respiratory tract infection (LRTI)
Proportion of participants with ≥1 episode of LRTI, by parental report
Time frame: Prior to first Diphtheria, Tetanus, Pertussis (DTP) vaccination
Lower respiratory tract infection (LRTI)
Proportion of participants with ≥1 episode of LRTI, by parental report
Time frame: 0-5 years of age
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Time frame: 0-12 months
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Time frame: Prior to first DTP vaccination
Rate of lower respiratory tract infection (LRTI)
Number of clinical episodes of LRTI, by parental report
Time frame: 0-5 years of age
Infections
Hospital admissions for any infection by parental report
Time frame: 0-12 months
Infections
Hospital admissions for any infection by parental report
Time frame: Prior to first DTP vaccination
Infections
Hospital admissions for any infection by parental report
Time frame: 0-5 years of age
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Time frame: 0-12 months of age
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Time frame: Prior to first DTP vaccination
Hospitalisation for respiratory tract infection (RTI)
Proportion of participants with ≥1 hospital admission for a RTI, by parent report
Time frame: 0-5 years of age
Rate of any infection
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
Time frame: 0-12 months of age
Rate of any infection
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
Time frame: Prior to first DTP vaccination
Rate of upper respiratory tract infection (URTI)
Number of clinical episodes of upper respiratory tract infections, by parent report
Time frame: 0-12 months of age
Rate of upper respiratory tract infection (URTI)
Number of clinical episodes of upper respiratory tract infections, by parent report
Time frame: Prior to first DTP vaccination
Rate of fever
Number of clinical episodes of fever, by parent report
Time frame: 0-12 months of age
Rate of fever
Number of clinical episodes of fever, by parent report
Time frame: Prior to first DTP vaccination
Diarrhoea
Proportion of participants with ≥1 episodes of diarrhoea
Time frame: 0-12 months of age
Diarrhoea
Proportion of participants with ≥1 episodes of diarrhoea
Time frame: Prior to first DTP vaccination
Rash with fever
Proportion of participants with ≥1 episodes of rash with fever
Time frame: 0-12 months of age
Rash with fever
Proportion of participants with ≥1 episodes of rash with fever
Time frame: Prior to first DTP vaccination
Eczema ever
Proportion of participants with eczema measured by a combined eczema measure
Time frame: 0-12 months of age
Eczema ever
Proportion of participants with eczema measured by a combined eczema measure
Time frame: 0-5 years of age
Eczema
Proportion of clinician-diagnosed eczema, by parental report
Time frame: 0-12 months
Eczema
Proportion of clinician-diagnosed eczema, by parental report
Time frame: 0-5 years of age
Eczema onset
Age of onset of eczema, by parental report
Time frame: 0-12 months
Eczema onset
Age of onset of eczema, by parental report
Time frame: 0-5 years of age
Eczema severity
Measured by parental report (POEM score)
Time frame: 0-12 months
Eczema severity
Measured by clinical assessment (SCORAD)
Time frame: 0-12 months
Eczema severity
Eczema medication use, by parental report
Time frame: 0-12 months
Eczema severity
Measured by parental report (POEM score)
Time frame: 0-5 years of age
Eczema severity
Measured by clinical assessment (SCORAD)
Time frame: 0-5 years of age
Eczema severity
Eczema medication use, by parental report
Time frame: 0-5 years of age
Asthma severity
Measured by asthma control test (ACT), by parental/participant report
Time frame: 4 years of age
Asthma severity
Measured by asthma control test (ACT), by parental/participant report
Time frame: 5 years of age
Asthma severity
Hospital admissions for asthma, by parental report
Time frame: 2-5 years of age
Laboratory measures of the immune response
Time frame: Time Frame: 0-5 years of age