M72/AS01E
Candidate Overview
The M72/AS01E vaccine candidate consists of the M72 fusion protein and the proprietary GSK adjuvant system AS01E.
Sponsor / Lead Developer: Gates Medical Research Institute
Development partner(s): GSK Vaccines (tech transfer and adjuvant development & supply)
Clinical Trial Status: Active Trials
Primary Indication: Prevention of TB disease
Target Population(s): Adolescents, Adults, People living with HIV, People with Mtb infection, and People without Mtb infection
Clinical Trials
ACTIVE TRIALS |
|
| Registry Number | NCT06062238 |
| Clinical Trial Phase | Phase 3 |
| Clinical Trial Sponsor | Gates Medical Research Institute |
| Primary endpoint(s) for this clinical trial | Prevention of TB disease |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
| People with Mtb infection | |
| People without Mtb infection | |
| People living with HIV | |
| Results/Publications | Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01E-4 tuberculosis vaccine (Vaccine, 2026) |
COMPLETED TRIALS (Phase 2 only) |
|
| Registry Number | NCT04556981 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | Gates Medical Research Institute |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
| People living with HIV | |
| Results/Publications | Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E–4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial |
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|
| Registry Number | NCT01755598 |
| Clinical Trial Phase | Phase 2b |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Prevention of TB disease |
| Target population(s) for clinical trial | Adults |
| People with Mtb infection | |
| Results/Publications | Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis(N Engl J Med, 2019) |
| Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis(N Engl J Med, 2018) | |
_________________________ |
|
| Registry Number | NCT01669096 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adults |
_________________________ |
|
| Registry Number | NCT01262976 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People living with HIV | |
_________________________ |
|
| Registry Number | NCT01098474 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Infants |
_________________________ |
|
| Registry Number | NCT00950612 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adolescents |
_________________________ |
|
| Registry Number | NCT00707967 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Target population(s) for clinical trial | People living with HIV |
_________________________ |
|
| Registry Number | NCT00621322 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
_________________________ |
|
| Registry Number | NCT00600782 |
| Clinical Trial Phase | Phase 2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
_________________________ |
|
| Registry Number | NCT00397943 |
| Clinical Trial Phase | Phase 1/2 |
| Clinical Trial Sponsor | GlaxoSmithKline |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
Related Publications
Additional Information
A multi-country, multi-site, epidemiologic study was conducted to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity for the Phase 3 trial (NCT05190146).
The clinical trial history currently lists trials from Phase 2 onwards.