Bacille Calmette-Guérin (BCG) Immune Response Study

Not Applicable

Recruiting

• Conditions: Tuberculosis; Immune response after BCG vaccine; Infection - Other infectious diseases

• Registration Number: ACTRN12608000227392
• Lead Sponsor: The Mercy Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Term, well newborn infants.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of cytokine (eg interferon-gamma) producing T cells measured by flow cytometry in samples after in vitro stimulation.[10 weeks after immunisation]

Secondary Outcome Measures

Name	Time	Method
Qualitative immune response measured as the pattern of cytokine producing T cells measured with flow cytometry and in supernatants using a multiplex bead array system.[10 weeks after immunisation]