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

This is an interventional prevention trial for Allergy focused on measuring BCG, Bacille Calmette Guérin, Allergy, Immunity, Immune response, Vaccine, Infants, Children, Infection Read More

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.