M72/AS01E

Vaccine Platform

Protein / Adjuvant

Phase of Development

Phase 2b

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
Gates MRI)
Registry NumberNCT04556981
Clinical Trial PhasePhase 2
StatusActive
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
Adolescents
People living with HIV
COMPLETED TRIALS (Sponsored by
GSK, Phase 2 only)
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Registry NumberNCT01755598
Clinical Trial PhasePhase 2b
StatusCompleted
Primary endpoint(s) for this clinical trialPrevention of TB disease
Target population(s) for clinical trialAdults
People with Mtb infection
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Registry NumberNCT01669096
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT01262976
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People living with HIV
_________________________
Registry NumberNCT01098474
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialInfants
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Registry NumberNCT00950612
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdolescents
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Registry NumberNCT00707967
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
Target population(s) for clinical trialPeople living with HIV
_________________________
Registry NumberNCT00621322
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT00600782
Clinical Trial PhasePhase 2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT00397943
Clinical Trial PhasePhase 1/2
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Primary endpoint(s) for this clinical trialImmunogenicity (confirm)
Target population(s) for clinical trialAdults

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.