Thembisa

Researchers are evaluating the safety, immune response, and effectiveness of a new tuberculosis vaccine called MTBVAC in healthy adolescents and adults aged 14 to 45 years who live in areas where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, involving participants with different immune responses to TB exposure as determined by IGRA testing. The study aims to protect against TB disease confirmed by multiple tests and focuses on those who are HIV-negative. Participants will be randomly assigned to receive either a single intradermal dose of the MTBVAC vaccine or a placebo. The vaccine dose contains approximately 5x10^5 colony-forming units, and the placebo is saline solution, both given as 0.1 mL injections. The study includes two groups based on IGRA status: one with prior immune response to TB and one without, with different randomization ratios. Some participants will be part of safety and immune response sub-cohorts for more detailed monitoring. Throughout the 36-month follow-up, participants will attend regular visits or be contacted to check for signs of TB. They will be trained to recognize TB symptoms and report them for further evaluation, including sputum testing using advanced molecular and culture methods. HIV testing will occur yearly and at times of suspected TB. Safety monitoring includes tracking adverse events and laboratory tests in selected subgroups. Participants diagnosed with TB will be referred for treatment according to local guidelines.

Researchers are evaluating the safety and bactericidal activity of TBD09 combined with other drugs in adults with drug-sensitive pulmonary tuberculosis. This Phase 2, open-label, randomized trial aims to assess whether TBD09, when used with bedaquiline, pretomanid, and linezolid, shows potential as a safe and effective treatment option for this condition. Participants are divided into five groups, each receiving different doses or combinations of TBD09 alongside bedaquiline and pretomanid or linezolid for 28 days. Group 1 receives TBD09 100 mg three times weekly, Groups 2 to 4 receive TBD09 daily at increasing doses (100 mg, 300 mg, 500 mg), and Group 5 receives linezolid 600 mg daily instead of TBD09. All treatments are administered daily or three times weekly depending on the group. Throughout the study, participants are monitored for bactericidal activity from randomization through Day 28 and safety from screening through Day 35. Researchers evaluate serious adverse events, treatment-emergent adverse events, adverse events of special interest, and events leading to treatment discontinuation. These assessments help determine the safety and effectiveness of the study treatments over the course of participation.