MTBVAC

Vaccine Platform

Mycobacterial – Live Attenuated

Phase of Development

Phase 3

Candidate Overview

MTBVAC is an attenuated M. tuberculosis strain, by genetically engineering two independent unmarked stable deletion mutations in the virulence genes phoP and fadD26, based on clinical strain of the Euro-American lineage 4, the most widespread transmitted lineage between humans. MTBVAC includes RD1 absent in BCG, which contains 23% of the known human T-cell epitopes present in M. tuberculosis.

Sponsor / Lead Developer: Biofabri

Development partner(s):

University of Zaragoza, IAVI, TBVI

Primary Indication: Prevention of TB disease

Target Population(s): Adolescents, Adults, and Infants

Clinical Trials

ACTIVE TRIALS
Registry NumberNCT04975178
Clinical Trial PhasePhase 3
SponsorBiofabri, S.L
Primary endpoint(s) for this clinical trialPrevention of disease
Target population(s) for clinical trialInfants
COMPLETED TRIALS
Registry NumberNCT03536117
Clinical Trial PhasePhase 2a
SponsorBiofabri, S.L
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialInfants
_________________________
Registry NumberNCT02933281
Clinical Trial PhasePhase 1b/2a
SponsorInternational AIDS Vaccine Initiative
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialAdults
Adolescents
_________________________
Registry NumberNCT02729571
Clinical Trial PhasePhase 1b
SponsorBiofabri, S.L
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialAdults
Adolescents
_________________________
Registry NumberNCT02013245
Clinical Trial PhasePhase 1a
SponsorBiofabri, S.L
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialInfants