RecruitingACTRN12608000227392

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


Sponsor

The Mercy Hospital for Women

Enrollment

256 participants

Start Date

Apr 26, 2008

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 2 Monthss

Inclusion Criteria1

  • Term, well newborn infants.

Exclusion Criteria1

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

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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 group

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.


Locations(1)

Australia

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