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

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.