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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.

NCT04556981 Protocol Version 3.0_Redacted.pdf