M72/AS01E

Phase of Development

Phase 3

Vaccine Platform

Protein / Adjuvant

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)

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 NumberNCT06062238
Clinical Trial PhasePhase 3
Clinical Trial SponsorBill & Melinda Gates Medical Research Institute
Primary endpoint(s) for this clinical trialPrevention of TB disease
Target population(s) for clinical trialAdults
Adolescents
People with Mtb infection
People without Mtb infection
People living with HIV
COMPLETED TRIALS (Phase 2 only)
Registry NumberNCT04556981
Clinical Trial PhasePhase 2a
Clinical Trial SponsorBill & Melinda Gates Medical Research Institute
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
Adolescents
People living with HIV
_________________________
Registry NumberNCT01755598
Clinical Trial PhasePhase 2b
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialPrevention of TB disease
Target population(s) for clinical trialAdults
People with Mtb infection
Results/PublicationsFinal 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)
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Registry NumberNCT01669096
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT01262976
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People living with HIV
_________________________
Registry NumberNCT01098474
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialInfants
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Registry NumberNCT00950612
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdolescents
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Registry NumberNCT00707967
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
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
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
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Registry NumberNCT00600782
Clinical Trial PhasePhase 2a
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT00397943
Clinical Trial PhasePhase 1/2
Clinical Trial SponsorGlaxoSmithKline
Primary endpoint(s) for this clinical trialSafety
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.

Source: Vaccine sponsor; ClinicalTrials.gov registry

Date Updated/Reviewed: 18-Jul-2022