Feb 16, 2022
NCT04556981 Safety and Immunogenicity of M72/AS01E in Participants With Well-controlled HIV (MESA-TB)
- Alexander Schmidt; Gates Medical Research Institute1
- 1Gates Medical Research Institute
- MESA-TB trial NCT04556981
External link: https://clinicaltrials.gov/ct2/show/NCT04556981
Protocol Citation: Alexander Schmidt; Gates Medical Research Institute 2022. NCT04556981 Safety and Immunogenicity of M72/AS01E in Participants With Well-controlled HIV (MESA-TB). protocols.io https://dx.doi.org/10.17504/protocols.io.b474qzqw
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it’s working
Created: February 16, 2022
Last Modified: February 16, 2022
Protocol Integer ID: 58332
Keywords: M72/AS01E investigational tuberculosis vaccine, Phase 2, clinical trial
Funders Acknowledgements:
Wellcome Trust
Grant ID: 221698/Z/20/Z
Bill & Melinda Gates Foundation
Grant ID: Gates MRI
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Abstract
Protocol Title: 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)
Short Title: Safety and immunogenicity of a TB vaccine M72/AS01E in participants with well controlled
HIV
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.
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