MTBVAC (BBV169)

Phase of Development

Phase 3

Vaccine Platform

Mycobacterial – Live Attenuated

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): Bharat Biotech, University of Zaragoza, IAVI, TBVI, HIV Vaccine Trials Network

Clinical Trial Status: Active Trials

Primary Indication: Prevention of TB disease

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

Clinical Trials

ACTIVE TRIALS
Registry NumberNCT04975178
Clinical Trial PhasePhase 3
Clinical Trial SponsorBiofabri, S.L
Primary endpoint(s) for this clinical trialPrevention of disease
Target population(s) for clinical trialInfants
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Registry NumberNCT06272812
Clinical Trial PhasePhase 2b
Clinical Trial SponsorInternational AIDS Vaccine Initiative
Primary endpoint(s) for this clinical trialPrevention of TB disease
Target population(s) for clinical trialAdolescents
Adults
People with Mtb infection
People without HIV infection
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Registry NumberNCT05947890
Clinical Trial PhasePhase 2a
Clinical Trial SponsorHIV Vaccine Trials Network
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialAdolescents
Adults
People living with HIV
People without HIV infection
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Registry NumberNCT06438978
Clinical Trial PhasePhase 1
Clinical Trial SponsorBharat Biotech International Limited
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People without Mtb infection
COMPLETED TRIALS
Registry NumberNCT03536117
Clinical Trial PhasePhase 2a
Clinical Trial SponsorBiofabri, S.L
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialInfants
Results/PublicationSafety, reactogenicity, and immunogenicity of MTBVAC in infants: a phase 2a randomised, double-blind, dose-defining trial in a TB endemic setting
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Registry NumberNCT02933281
Clinical Trial PhasePhase 1b/2a
Clinical Trial SponsorInternational AIDS Vaccine Initiative
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialAdults
Adolescents
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Registry NumberNCT02729571
Clinical Trial PhasePhase 1b
Clinical Trial SponsorBiofabri, S.L
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialAdults
Adolescents
Results/PublicationLive-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial
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Registry NumberNCT02013245
Clinical Trial PhasePhase 1a
Clnical Trial SponsorBiofabri, S.L
Primary endpoint(s) for this clinical Safety
Target population(s) for clinical trialInfants
Results/PublicationSafety of human immunisation with a live-attenuated Mycobacterium tuberculosis vaccine: a randomised, double-blind, controlled phase I trial

Related Publications

  1. Live attenuated TB vaccines representing the three modern Mycobacterium tuberculosis lineages reveal that the Euro–American genetic background confers optimal vaccine potential (EBioMedicine, 2020)
  2. Reactogenicity to major tuberculosis antigens absent in BCG is linked to improved protection against Mycobacterium tuberculosis (Nat. Commun., 2017)
  3. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials (Vaccine, 2013)

Source: Vaccine Sponsor, Trial Sponsor, ClinicalTrials.gov, Online press release

Date Updated/Reviewed: 11-Apr-2025