MESA-TB Gates MRI
MESA-TB Gates MRI : A Randomized, Placebo-Controlled, Observer-Blind, Phase 2 Study to Evaluate the Safety and Immunogenicity of the Investigational M72/AS01E Mycobacterium tuberculosis (Mtb) Vaccine in Virally Suppressed, Antiretroviral-Treated Participants with Human Immunodeficiency Virus (HIV).
Rationale
Previous phase 1 and 2 randomized controlled trials have demonstrated that the M72/AS01E vaccine is safe and immunogenic in HIV-positive individuals receiving antiretroviral therapy (ART). Administered in a two-dose schedule one month apart, the vaccine was well-tolerated in this population. This study aims to confirm the vaccine’s safety and immunogenicity in a larger cohort of virally suppressed HIV-infected individuals in a tuberculosis (TB) endemic region.
Primary Objectives
- To assess the safety and reactogenicity of M72/AS01E vaccination.
Secondary Objectives
- To evaluate the safety of M72/AS01E vaccination.
- To measure the humoral immunogenicity of M72/AS01E vaccination.
- To assess the cellular immunogenicity of M72/AS01E vaccination.
Investigators
- Prof Lee Fairlie, Principal Investigator
- Dr Faeezah Patel, Sub Investigator
- Dr Elizea Horne, Sub Investigator
Media Coverage
- Press Release, 19 March: Bill & Melinda Gates Medical Research Institute
- Press Release, 19 March: The Wellcome Trust
- SABC News: South Africa launches clinical trial for experimental TB vaccine: Prof Lee Fairlie
Latest Update
April 2024
For more about MESA-TB Gates MRI study please email rhicomms@wrhi.ac.za
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