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NCT06205589 · ClinicalTrials.gov record · last posted 2026-08-24

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

StatusNot Yet Recruiting
PhasePhase 2
Started2027-01-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 5 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 5 times since 2024-01-04; most recent amendment 2026-04-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT06205589
Lead Sponsor Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Tuberculosis, Pulmonary
Enrollment 1,500 participants
Start Date 2027-01-31
Primary Completion 2028-10-31 (estimated)
Study Completion 2029-10-13 (estimated)
Updated on ClinicalTrials.gov 2026-08-24