Tuberculosis
Conditions
Interventions
ID93 plus GLA SE plus Standard TB drugs
standard TB treatment RHZ based regimen plus Placebo injections
Sponsors
National Institute of Allergy and Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible for inclusion if they meet all of the following criteria: Adults aged =18 years Bacteriologically confirmed rifampicin-susceptible pulmonary tuberculosis Currently receiving locally provided standard of care TB treatment For participants living with HIV: On stable antiretroviral therapy (ART) for at least 3 months HIV-1 RNA below the limit of detection (virally suppressed) CD4+ cell count =250 cells/mm³ Willing and able to comply with study procedures and follow-up visits Able to provide informed consent
Exclusion criteria
Exclusion criteria: Participants are excluded if any of the following apply: Co-enrollment in another study involving an investigational research agent (unless approved by Protocol Chairs and DAIDS Clinical Representatives) Any clinically significant condition that could affect immune function or increase risk from vaccination or blood draws, including: Use or initiation of immunosuppressive medications Pregnancy at any time (regardless of outcome) Any serious adverse event (SAE) considered related to study vaccination Any Grade 4 adverse event, local or systemic reactogenicity, or laboratory abnormality related to study vaccination Grade 3 adverse event related to study vaccine (except fever and expected local/systemic symptoms; certain injection site reactions may be reviewed for continuation) Newly identified adverse events of special interest (AESI) Clinically significant type 1 hypersensitivity reaction (e.g., anaphylaxis, angioedema, urticaria, bronchospasm, laryngospasm) related to study vaccination without prior CMC consultation for further dosing Participant request to permanently discontinue vaccination Post-entry detection of isoniazid resistance requiring discontinuation of study product (where applicable) Any condition or circumstance that, in the investigator’s judgment (in consultation with the Clinical Management Committee), makes continued participation not in the participant’s best interest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (e.g., vaccine-related SAEs, Grade =3 AEs) Immunogenicity (CD4+ T-cell responses, IgG responses) Efficacy (TB-related unfavorable outcomes in Phase 2b) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity (additional cellular and humoral responses): measured at multiple time points up to 12 months post–second dose, including visits around Days 60, 120, 150, 240, 300, and 420–510 depending on group. Efficacy-related clinical outcomes (e.g., RS ratio, culture conversion, lung function, SGRQ scores): assessed at approximately 6, 12, and 18 months after TB treatment initiation, corresponding to group-specific visits (e.g., Days 60–150, 240–330, and 420–510). | — |
Countries
Kenya
Contacts
Public ContactLaura Moran
ACTG Clinical Trials Specialists
Outcome results
None listed