BCG Revaccination in Children and Adolescents

Launched by TUBERCULOSIS RESEARCH CENTRE, INDIA · Apr 8, 2022

Keywords

ClinConnect Summary

Objectives

Primary:

To demonstrate the effect of BCG revaccination in comparison to oral chemoprophylaxis on the incidence of Mycobacterium tuberculosis disease in healthy household contacts aged 6-18 years.

Secondary:

* To compare the safety of BCG revaccination with oral chemoprophylaxis
* To study the efficacy of BCG revaccination in comparison to oral chemoprophylaxis in preventing Mycobacterium tuberculosis infection
* To study the immunogenicity of BCG revaccination

Methodology The aim of this study is to assess the efficacy of BCG revaccination compared to oral chemoprophylaxis ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy household contacts aged 6 to 18 yr
• • Previously vaccinated with BCG at birth or least 5 years ago - evidence of scar or documented immunisation record.
• • General good health - through history and baseline screening
• • Agrees to continue in the study for 2 years post enrollment
• • Children previously treated for LTBI and completed treatment at least 6 months ago - can also be included. However, they should be current HHC
• Exclusion Criteria:
• • Any acute illness on recruitment day (Evaluate the child again at a later stage)
• • Fever ≥38 degree Celsius on recruitment day (Evaluate the child again at a later)
• • History of autoimmune disease
• • Pregnancy - female participants \> 15 years of age will have pregnancy test done after caretakers and participants informed consent
• • Evidence of active TB disease
• • On treatment for active TB disease or LTBI
• • HIV positive or any history or present possible immunodeficiency condition
• • History of allergic reactions to vaccines in past
• • Pre-existing liver dysfunction
• • ALT/AST is ≥ 3 times upper limit of normal (ULN) in the presence of symptoms or ≥ 5 times the ULN in the absence of symptoms and/or total bilirubin greater than ULN along with raised ALT/AST.