A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study

Inclusion criteria

• English speaking parent
• Planned travel to a TB (Tuberculosis) endemic country within the infant's first 5 years of life
• An informed consent form must be signed and dated by the infant's mother 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
• The infant's mother has screened negative for Hepatitis B during this pregnancy
• There is no known household contact infected with Hepatitis B
• Born no earlier than eight weeks before estimated date of delivery
• Birth weight >1500g
• Delivered vaginally
• Singleton pregnancy

Exclusion criteria

• 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 (biological Disease- Modifying Anti-Rheumatic drugs) (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

Also excluded are infants with:

• A mother who is immunosuppressed;
• A mother who has received Intravenous immunoglobulins during her pregnancy
• A family history of immunodeficiency;
• Consanguineous parents.
• Mother who is having a planned Caesarean Section
• A home address more than 40 minutes drive from the Mercy hospital for Women and are unwilling to return to hospital for infant blood sampling