BCG Revax Gates MRI
Infectious Diseases
A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG revaccination in Healthy Adolescents for the Prevention of Sustained Infection with Mycobacterium tuberculosis.
Rationale
The study is focused on evaluating the efficacy, safety, and immunogenicity of Bacillus Calmette-Guerin (BCG) revaccination in healthy adolescents for the prevention of sustained infection with Mycobacterium tuberculosis (Mtb). The key points of the rationale include:
- Previous Study Results: It references recently published results from a Phase 2 study that suggest BCG revaccination in healthy adolescents may prevent sustained Mtb infection over a 24-month period.
- Confirmation and Duration of Protection: The study aims to confirm the protective effect of BCG revaccination against sustained Mtb infection in a larger independent study. It also seeks to assess the duration of protection for at least 48 months post-revaccination.
- Expansion to Different Age Groups: This study expands the age group to include children aged ten years and above, potentially broadening the understanding of BCG revaccination efficacy across different age cohorts.
- Biomarker Identification: It aims to identify and validate biomarkers that correlate with the risk for or protection against transient and/or sustained Mtb infection, using the newer version of the QuantiFERON-TB Gold assay (QFT), known as QuantiFERON plus (QFT).
Investigators
- Dr Lee Fairlie (Principal Investigator)
- Dr Jeanne Coetzee (Principal Investigator)
- Dr Faeezah Patel (Sub Investigator)
- Dr Elizea Horne (Sub Investigator)
- Dr Mrinmayee Dhar
- Dr Muneerah Khan
- Dr Pemphero Chasela
Latest Update
September 2023
For more details about the BCG Revax Gates MRI Study please email rhicomms@wrhi.ac.za
