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mtbvac
- Development stage
- Phase 3
- Lead developer
- Biofabri
- Modality
- Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Vaccines & Immunotherapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Intradermal, Intravesical
01
Overview
MTBVAC is a live-attenuated vaccine candidate for the prevention of tuberculosis (TB), developed as a potential replacement for the Bacille Calmette-Guérin (BCG) vaccine. Unlike BCG, which is derived from Mycobacterium bovis, MTBVAC is based on a genetically modified human isolate of Mycobacterium tuberculosis (lineage 4). The vaccine contains two independent stable deletions in the virulence genes phoP and fadD26, resulting in attenuation while preserving most T cell epitopes found in wild-type M. tuberculosis—including ESAT6 and CFP10 antigens absent from BCG. This design aims to induce robust and long-lasting immune responses that closely mimic natural infection without causing disease. MTBVAC has demonstrated safety and immunogenicity comparable or superior to BCG in clinical trials and is currently being evaluated in phase 3 studies for TB prevention in newborns, adolescents, and adults[1][2][3][5].
- Brand names
- MTBVAC BOOSTER
- Other names
- MTBVACBBV169BBV-169BBV 169
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