This trial is active, not recruiting.

Conditions allergy, eczema, respiratory tract infections
Treatment bcg
Phase phase 3
Sponsor Murdoch Childrens Research Institute
Collaborator Royal Children's Hospital
Start date July 2013
End date December 2017
Trial size 1438 participants
Trial identifier NCT01906853, 1051228, BCG12/01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
(No Intervention)
Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
bcg BCG vaccine - Denmark strain

Primary Outcomes

Prevalence of positive skin prick tests
time frame: At 12 months of age
Prevalence of eczema
time frame: 0-12 months of age
Prevalence of lower respiratory tract infections
time frame: 0-12 months of age

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 10 days old.

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.

Additional Information

Official title A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants
Principal investigator Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Murdoch Childrens Research Institute.