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: Bill & Melinda Gates Medical Research Institute
Development partner(s): GSK Vaccines (tech transfer and adjuvant development & supply)
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 (Sponsored by |
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| Registry Number | NCT04556981 |
| Clinical Trial Phase | Phase 2 |
| Status | Active |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
| People living with HIV | |
COMPLETED TRIALS (Sponsored by |
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| Registry Number | NCT01755598 |
| Clinical Trial Phase | Phase 2b |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Prevention of TB disease |
| Target population(s) for clinical trial | Adults |
| People with Mtb infection | |
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| Registry Number | NCT01669096 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adults |
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| Registry Number | NCT01262976 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People living with HIV | |
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| Registry Number | NCT01098474 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Infants |
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| Registry Number | NCT00950612 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adolescents |
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| Registry Number | NCT00707967 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| 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 |
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| Registry Number | NCT00621322 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
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| Registry Number | NCT00600782 |
| Clinical Trial Phase | Phase 2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
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| Registry Number | NCT00397943 |
| Clinical Trial Phase | Phase 1/2 |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Primary endpoint(s) for this clinical trial | Immunogenicity (confirm) |
| Target population(s) for clinical trial | Adults |
Related 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)
Additional Information
Phase 3 trial in planning. The clinical trial history currently lists trials from Phase 2 onwards. Phase 1 trials may be added at a later time.