Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV

Exclusion Criteria

• •Acute illness or fever ≥99.5°F (or ≥37.5˚C) on Day 1
• •History of active TB disease
• •Evidence of active TB disease with any of the following:
• •* Have symptoms or signs of TB disease
• •* Have a positive sputum Xpert MTB/RIF assay (only in participants with sputum sample at screening)
• •* Are on treatment for active TB disease
• •Evidence and/or history of clinically significant medical conditions (other than HIV infection) as judged by the investigator, including malignancies
• •Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
• •Any medications or other therapies that may impact the immune system such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with major organ toxicity as determined by the investigator, within 90 days prior to Day 1
• •Immunosuppressive agents including systemic steroids - prior corticosteroid therapy within 90 days prior to Day 1 (permitted: 5 mg/day prednisone equivalent, inhaled, topical, and intra-articular corticosteroids)
• •Receipt or donation of blood or blood products within 90 days prior to Day 1 or planned receipt or donation during the study period
• •Participation in an interventional clinical trial and/or receipt of any investigational drug within 180 days prior to signing informed consent or assent
• •Receipt of any vaccine in the period starting 7 days before, and ending 7 days after, each dose of the study vaccine
• •History of previous administration of experimental Mycobacterium tuberculosis vaccine
• •Safety laboratory values outside of normal range, for age and sex that are suggestive of a disease state (Grade 1 abnormalities, as per Division of AIDS \[DAIDS\] toxicity table version 2.1, will not lead to exclusion if the investigator considers them not clinically significant.)
• •Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
• •Current hepatitis B and/or hepatitis C infection
• •Indeterminate QFT result
• •History of allergy or hypersensitivity to the study drug, excipients or related substances
• •Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB, e.g., Xpert MTB/RIF assay-positive, polymerase chain reaction (PCR)-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB
• •Female participants with any one of the following conditions: currently pregnant or lactating/nursing; having positive serum pregnancy test during the screening window, planning a pregnancy within 1 year after first dose of study product
• •Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel.
• •Child in Care