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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906853
First Posted: July 24, 2013
Last Update Posted: September 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
  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 Intervention Phase
Allergy Eczema Respiratory Tract Infections Biological: BCG Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Prof Nigel Curtis, Murdoch Childrens Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 1438
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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.
  Contacts and Locations
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
  More Information

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 Submitted: July 21, 2013
First Posted: July 24, 2013
Last Update Posted: September 14, 2016
Last Verified: September 2016

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