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

Target Route of Administration: Intramuscular

Clinical Trials

ACTIVE TRIALS
Registry Number	NCT06062238
Clinical Trial Phase	Phase 3
Clinical Trial Sponsor	Bill & Melinda 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
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COMPLETED TRIALS (Phase 2 only)
Registry Number	NCT04556981
Clinical Trial Phase	Phase 2a
Clinical Trial Sponsor	Bill & Melinda Gates Medical Research Institute
Primary endpoint(s) for this clinical trial	Safety
Target population(s) for clinical trial	Adults
	Adolescents
	People living with HIV
_________________________
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
Target population(s) for clinical trial	People with Mtb infection
_________________________
Registry Number	NCT01669096
Clinical Trial Phase	Phase 2a
Clinical Trial Sponsor	GlaxoSmithKline
Primary endpoint(s) for this clinical trial	Safety
Primary endpoint(s) for this clinical trial	Immunogenicity
Target population(s) for clinical trial	Adults
_________________________
Registry Number	NCT01262976
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	NCT01098474
Clinical Trial Phase	Phase 2a
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 2a
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 2a
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 2a
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