drugset / Trial / NCT06205589

Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB

NCT06205589

RandomizedSequentialDouble-blindTreatment

Summary

This study is being done to test an experimental study vaccine compared to a placebo. The experimental study vaccine is called ID93 + GLA-SE. ID93 + GLA-SE has been used in humans in research but has not been approved for use in medical care. This study will be the first to test ID93 + GLA-SE in people living with HIV (PLWH). The injections during the study will be given to different groups of participants while they are using standard TB treatment. One of the research questions is to understand the differences in immune system responses depending on the timing of giving the injections after people begin taking standard TB treatment. Researchers also want to continue to look at whether the study vaccine is safe when tested in a larger group of people, and if getting the study vaccine in addition to standard TB treatment can help to lower the number of poor TB outcomes that people might have.

Timeline

Start
2026-07-01
Primary completion
2028-10-31
Completion
2029-10-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator ID93 Protein / enzyme biologic 0.5 ml Intramuscular