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Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction (MIS BAIR)

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ClinicalTrials.gov Identifier: NCT01906853
Recruitment Status : Active, not recruiting
First Posted : July 24, 2013
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Royal Children's Hospital
Mercy Hospital for Women, Australia
University of Melbourne
Information provided by (Responsible Party):
Prof Nigel Curtis, Murdoch Childrens Research Institute

July 21, 2013
July 24, 2013
December 22, 2017
July 2013
December 2021   (Final data collection date for primary outcome measure)
  • Prevalence of positive skin prick tests [ Time Frame: At 1 and 5 years of age ]
    Positive skin prick test defined as average wheal diameter ≥2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
  • Prevalence of eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Eczema measured by the Williams' UK diagnostic criteria by parental report
  • Prevalence of lower respiratory tract infections [ Time Frame: 0-12 months and 0-5 years of age ]
    Measured by the parent report of lower respiratory tract infections
  • Current asthma [ Time Frame: 5 years of age ]
    Using ISAAC definitions
  • Asthma ever [ Time Frame: 5 years of age ]
    Using ISAAC definitions
  • Lower respiratory tract illness (LRTI) [ Time Frame: 0-5 years of age ]
    Hospital admissions for LRTI
  • 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
Complete list of historical versions of study NCT01906853 on ClinicalTrials.gov Archive Site
  • Clinical food allergy in participants with a positive SPT [ Time Frame: At 1 and 5 years of age ]
    Challenge proven or convincing history of food allergy
  • Anaphylaxis [ Time Frame: 0-12 months and 0-5 years of age ]
    Proportion of participants with ≥1 anaphylaxis episode
  • Lower respiratory tract illness (LRTI) [ Time Frame: 0-12 months of age ]
    Hospital admissions for LRTI
  • Infections [ Time Frame: 0-12 months and 0-5 years of age ]
    Hospital admissions for any infection
  • Lower respiratory tract illness (LRTI) [ Time Frame: 0-12 months and 0-5 years of age ]
    Number of clinical episodes of LRTI
  • Neonatal infections [ Time Frame: 0-12 months and 0-5 years of age ]
    Early and late onset neonatal sepsis
  • Laboratory measures of the immune response [ Time Frame: 0-5 years of age ]
  • Severity of eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Parent report of severity (POEM score), clinical assessment (SCORAD), eczema medication use, steroid use
  • Eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Doctor diagnosed eczema
  • Eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Age of onset of eczema
  • Severity of asthma [ Time Frame: 4 and 5 years of age ]
    Asthma Control Test in participant- & parent-completed questionnaires
  • Severity of asthma [ Time Frame: 2-5 years of age ]
    Hospital admissions for asthma
  • Morbidity [ Time Frame: 0-12 months and 0-5 years of age ]
    Hospital admissions for any reason
  • 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 ]
    Joint meta-analysis with data from the Danish Calmette study (NCT01694108)
  • A sub-group analysis of the effect of presence or absence BCG scar on the non-specific effects of BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of maternal BCG on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of sex on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of timing of BCG administration on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of mode of delivery on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of family history of allergy on the allergy and eczema outcomes [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of season of birth on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years of age ]
  • A sub-group analysis of the effect of hepatitis B vaccine timing birth on the non-specific effects BCG [ Time Frame: 0-12 months and 0-5 years 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 ]
 
Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants
  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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Allergy
  • Eczema
  • Respiratory Tract Infections
Biological: BCG
Other Names:
  • BCG vaccine - Denmark strain
  • BCG Denmark
  • Statens Serum Institute BCG vaccine
  • Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331
  • No Intervention: No BCG
    No BCG
  • Experimental: BCG
    Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
    Intervention: Biological: BCG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1272
1400
July 2022
December 2021   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Less than 10 days old;
  • English speaking mother;
  • An informed consent form must be signed and dated by their parent(s) or legally acceptable representative after the nature of the study has been explained and prior to any study assessments/procedures;
  • The infant's mother has screened negative for HIV during this pregnancy;
  • Born no earlier than eight weeks before estimated date of delivery;
  • Birth weight >1500g.
  • The legal guardian expects to be able to complete four online/phone questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing at RCH between 12-16 months of age.

Exclusion criteria:

  • Any indication for BCG immunisation in the first 12 months of life including:

    • likely travel to a high tuberculosis (TB) incidence country in the first year of life.
    • Aboriginal and Torres Strait Islander babies living in parts of Australia where the incidence of TB is higher
    • newborn babies, if either parent has leprosy or a family history of leprosy
    • newborn in contact with a patient with TB.
  • Known or suspected HIV infection
  • Treatment with corticosteroids or other immunosuppressive therapy, including monoclonal antibodies against tumour necrosis factor-alpha (TNF-alpha) (e.g. infliximab, etanercept, adalimumab).
  • Born to a mother treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies) in the 3rd trimester;
  • Congenital cellular immunodeficiencies including specific deficiencies of the interferon gamma pathway;
  • Malignancies involving bone marrow or lymphoid systems;
  • Serious underlying illness including severe malnutrition;
  • Medically unstable;
  • Generalised septic skin disease and skin conditions such as eczema, dermatitis and psoriasis;
  • Significant febrile illness;
  • Mother immunosuppressed;
  • Family history of immunodeficiency;
  • Consanguineous parents;
  • Multiple births more than twins.
Sexes Eligible for Study: All
up to 10 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01906853
BCG12/01
1051228 ( Other Grant/Funding Number: National Health and Medical Research Council (NHMRC) )
No
Not Provided
Not Provided
Prof Nigel Curtis, Murdoch Childrens Research Institute
Murdoch Childrens Research Institute
  • Royal Children's Hospital
  • Mercy Hospital for Women, Australia
  • University of Melbourne
Principal Investigator: Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne
Murdoch Childrens Research Institute
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP