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

Plain Language Summary

Simplified for easier understanding

This study is investigating how the BCG vaccine (the tuberculosis vaccine often given to newborns) affects the immune system in babies. Researchers want to understand how the vaccine strain and the age at which babies are vaccinated affects the type and strength of the immune response, which may relate to how well the vaccine protects them. You may be eligible if: - Your baby is a healthy full-term newborn - Your baby is between 1 day and 2 months old You may NOT be eligible if: - There is a family history of immune deficiency disorders - The mother has HIV - The mother has active tuberculosis (TB) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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ACTRN12608000227392


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