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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

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.

Condition or disease Intervention/treatment Phase
Allergy Eczema Respiratory Tract Infections Biological: BCG Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants
Study Start Date : July 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
No Intervention: No BCG
No BCG
Experimental: BCG
Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
Biological: BCG
Other Names:
  • BCG vaccine - Denmark strain
  • BCG Denmark
  • Statens Serum Institute BCG vaccine
  • Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Current asthma [ Time Frame: 5 years of age ]
    Using ISAAC definitions

  5. Asthma ever [ Time Frame: 5 years of age ]
    Using ISAAC definitions

  6. Lower respiratory tract illness (LRTI) [ Time Frame: 0-5 years of age ]
    Hospital admissions for LRTI


Secondary Outcome Measures :
  1. 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

  2. Anaphylaxis [ Time Frame: 0-12 months and 0-5 years of age ]
    Proportion of participants with ≥1 anaphylaxis episode

  3. Lower respiratory tract illness (LRTI) [ Time Frame: 0-12 months of age ]
    Hospital admissions for LRTI

  4. Infections [ Time Frame: 0-12 months and 0-5 years of age ]
    Hospital admissions for any infection

  5. Lower respiratory tract illness (LRTI) [ Time Frame: 0-12 months and 0-5 years of age ]
    Number of clinical episodes of LRTI

  6. Neonatal infections [ Time Frame: 0-12 months and 0-5 years of age ]
    Early and late onset neonatal sepsis

  7. Laboratory measures of the immune response [ Time Frame: 0-5 years of age ]
  8. 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

  9. Eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Doctor diagnosed eczema

  10. Eczema [ Time Frame: 0-12 months and 0-5 years of age ]
    Age of onset of eczema

  11. Severity of asthma [ Time Frame: 4 and 5 years of age ]
    Asthma Control Test in participant- & parent-completed questionnaires

  12. Severity of asthma [ Time Frame: 2-5 years of age ]
    Hospital admissions for asthma

  13. Morbidity [ Time Frame: 0-12 months and 0-5 years of age ]
    Hospital admissions for any reason


Other Outcome Measures:
  1. Joint meta-analysis of data [ Time Frame: 36 months ]
    Joint meta-analysis with data from the Danish Calmette study (NCT01694108)

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906853


Locations
Australia, Victoria
Mercy Hospital for Women
Heidelberg, Victoria, Australia, 3084
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Murdoch Childrens Research Institute
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

Responsible Party: Prof Nigel Curtis, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT01906853     History of Changes
Other Study ID Numbers: BCG12/01
1051228 ( Other Grant/Funding Number: National Health and Medical Research Council (NHMRC) )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Prof Nigel Curtis, Murdoch Childrens Research Institute:
BCG
Bacille Calmette Guérin
Allergy
Immunity
Immune response
Vaccine
Infants
Children
Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hypersensitivity
Respiratory Tract Infections
Immune System Diseases
Respiratory Tract Diseases
Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic