Bacille Calmette-Guérin (BCG) Immune Response Study

Improving protection against childhood tuberculosis: the influence of Bacille Calmette-Guérin (BCG) vaccine strain and age on protective immunity

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000227392

Acronym

BIRS

Enrollment

256

Registered

2008-05-02

Start date

2008-04-26

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is investigating the influence of vaccine strain and age at immunisation on the immune response in children to Bacille Calmette-Guérin (BCG) immunisation. The underlying hypothesis is that there is a measurable difference in the qualtitative and qualitative immune response which may be associated with differences in the level of protection

Interventions

Use of three different BCG vaccine strains (BCG-Denmark, BCG-Japan, BCG-Russia) for immunisation at birth. Immunisation at 2 months of age with one BCG vaccine strain (BCG-Denmark). In all study groups 0.05ml of BCG will be administered intradermally.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

1 Days to 2 Months

Healthy volunteers

Inclusion criteria

Term, well newborn infants.

Exclusion criteria

Family history of immunodeficiencies. Mother with HIV. Mother with active TB.

Outcome results