NCT04556981 Safety and Immunogenicity of M72/AS01E in Participants With Well-controlled HIV (MESA-TB) v1

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.