MESA-TB Gates MRI

A randomized, placebo-controlled, observer-blind, phase 2 study to evaluate safety and immunogenicity of the investigational M72/AS01E Mycobacterium tuberculosis (Mtb) vaccine in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus (HIV) p>

Rationale

Published phase 1 and 2 randomized, controlled trials evaluating M72/AS01E vaccination in individuals with HIV who were receiving antiretroviral therapy (ART) show that a 2-dose schedule of the vaccine given one month apart is well-tolerated and immunogenic in this population. This current study intends to confirm that the vaccine is safe, well-tolerated, and immunogenic in a larger population of people with virally suppressed HIV infection in a tuberculosis (TB) endemic region.

Primary Objectives

To assess the safety and reactogenicity of M72/AS01E vaccination

Primary Endpoint/Outcome

• Solicited adverse events (AEs) through 7 days post each dose of study intervention

• Unsolicited AEs through 28 days post each dose of study intervention

• All serious adverse events (SAEs) through end of study

Study Design

This is randomized, observer-blind, placebo-controlled, clinical trial of M72/AS01E tuberculosis vaccine vs. placebo in approximately 400 males and females between 16 to 35 years of age inclusive, who are living with HIV infection, and are virally suppressed (i.e., viral load < 200 copies per mL) on ART.

Study Population

Adolescents 16-35 Years of age

Investigators

Prof Lee Fairlie, Principal Investigator

Dr Masebole Masenya, Sub Investigator

Dr Faeezah Patel, Sub Investigator

Dr Elizea Horne, Sub Investigator

Sponsors/Donors

Bill and Melinda Gates Medical Research Institute (Gates MRI)


Latest Update: 23 August 2021

For more about MESA-TB Gates MRI please email rhicomms@wrhi.ac.za