BCG Revax Gates MRI
Given its heavy burden of TB-associated disease and death, South Africa has a major interest in the development of an effective new TB vaccine. The only available vaccine, the Bacille Calmette-Guérin (BCG) vaccine, was developed 80 years ago. Several vaccine candidates are currently in the pipeline, and the M72/ASO1E candidate vaccine (M72) generated considerable excitement in 2018 when the first results from a phase IIB trial indicated it was 50% effective in reducing pulmonary TB in adults with latent TB infection.
Wits RHI was part of a multisite study to evaluate the safety and immunogenicity of the M72 vaccine in people living with HIV, who are taking ART and are virally suppressed (MESA-TB). This has set the stage for a phase III study on M72, CommuniTB, due to start in early 2024. The study is funded by the Bill and Melinda Gates Medical Research Institute. Lee Fairlie is the National PI and is the chair of the trial steering committee.
Objective
Recently published results from a Phase 2 study evaluating Bacillus Calmette‐Guerin (BCG) revaccination in healthy adolescents in South Africa suggest that BCG revaccination of adolescents 12 to 17 years of age may lead to prevention of sustained Mycobacterium tuberculosis (Mtb) infection (POSI) over a 24 month period
following vaccination, as assessed by sustained QuantiFERON‐TB Gold® in‐Tube (QFT GIT) conversion (ie, initial QFT conversion and remaining QFT positive at three and six months post conversion) (Nemes, 2018). This current study intends to i) confirm that BCG revaccination protects against sustained Mtb infection in a larger
independent study, ii) assess the duration of protection through at least 48 months post revaccination, iii) evaluate BCG revaccination in children ten years of age and above and iv) identify/validate biomarkers that correlate with risk for or protection against transient and/or sustained Mtb infection, as assessed by QuantiFERON plus (QFT) assay, which is the newer version of the QFT GIT assay.
Investigators
- Dr Lee Fairlie, Principal Investigator
- Dr Masebole Masenya, Sub Investigator
- Dr Faeezah Patel, Sub Investigator
- Dr Elizea Horne, Sub Investigator
Other Partners & Collaborators
- AQVIA
- BARC
Sponsors/Donors
- Bill and Melinda Gates Medical Research Institute (Gates MRI)
Latest Update
- 15 February 2021
For more about BCG REVAX please email rhicomms@wrhi.ac.za
