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.
Bacteriologically confirmed rifampicin-susceptible pulmonary TB using phenotypic drug susceptibility testing or a World Health Organization (WHO) approved molecular test.
Documentation of HIV status as positive or negative by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit.
For individuals with HIV, on locally approved HIV ART for at least 90 days prior to entry.
For individuals with HIV, CD4+ cell count ≥250 cells/mm3 obtained within 90 days prior to entry at any network-approved non-US laboratory that is DAIDS IQA certified.
Documented M.tb resistance to isoniazid.
Breastfeeding.
Any previous episode of TB treatment.
TB treatment with a local non-standard first-line TB treatment regimen at time of enrollment.
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Treatment groupsSee each treatment group below.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator