Active — Not RecruitingPhase 3

Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

Indonesia20,080 participantsStarted 2024-03-05

Plain-language summary

The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.

Who can participate

Age range15 Years – 44 Years

SexALL

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Inclusion criteria

✓. Have reactive anti-HIV antibody at screening.
✓. Have been on antiretroviral therapy (ART) for at least 3 consecutive months at screening and agree to remain on ART throughout the trial.
✓. Have documented HIV Ribonucleic acid (RNA) \<200 copies per milliliter (/mL) at screening.
✓. Have Cluster of differentiation (CD)4+ cell count ≥200 cells/microliter (μL) at screening.
✓. Have had Tuberculosis preventive therapy (TPT) in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators.
✓. Have an IGRA-positive or negative result at screening.

What they're measuring

IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)

Timeframe: Up to Month 49

Trial details

NCT IDNCT06062238

SponsorGates Medical Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

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