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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety (Phase 2a and Phase 2b): Vaccine-related serious adverse event (SAE)
Timeframe: From Step 2, Day 0 through to 420, 450, 480 or 510 days (approximately 18 months after start of SOC treatment)
Safety (Phase 2a and Phase 2b): Grade ≥3 vaccine-related unsolicited adverse event (AE)
Timeframe: Within 28 days from Step 2, Day 0 or Step 2, Day 60
Safety (Phase 2a and Phase 2b): Grade ≥3 local or systemic reactogenicity AE
Timeframe: Within 7 days from Step 2, Day 0 or Step 2, Day 60
Cellular immunogenicity (Phase 2a and Phase 2b): ID93-specific CD4+ T cell response relative to the negative control stimulation
Timeframe: Step 2, Day 75
Cellular immunogenicity (Phase 2a and Phase 2b): ID93-specific CD4+ T cell response relative to the negative control stimulation and relative to the pre-vaccine response
Timeframe: Step 2, Day 75
Cellular immunogenicity (Phase 2a and Phase 2b): ID93-specific CD4+ T cell response magnitude relative to the negative control stimulation
Timeframe: Step 2, Day 75
Efficacy (Phase 2b): Bacteriologically confirmed TB-related unfavorable outcome (treatment failure, TB recurrence, or death due to TB)
Timeframe: Step 2, Day 0 to 420, 450, 480 or 510 days (approximately 18 months after start of SOC treatment)