MTBVAC
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 Number | NCT04975178 |
| Clinical Trial Phase | Phase 3 |
| Clinical Trial Sponsor | Biofabri, S.L |
| Primary endpoint(s) for this clinical trial | Prevention of disease |
| Target population(s) for clinical trial | Infants |
_________________________ |
|
| Registry Number | NCTNCT05947890 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | HIV Vaccine Trials Network |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adolescents |
| Adults | |
| People living with HIV | |
| People without HIV infection | |
COMPLETED TRIALS |
|
| Registry Number | NCT03536117 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Biofabri, S.L |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Infants |
_________________________ |
|
| Registry Number | NCT02933281 |
| Clinical Trial Phase | Phase 1b/2a |
| Clinical Trial Sponsor | International AIDS Vaccine Initiative |
| Primary endpoint(s) for this clinical | Safety |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
_________________________ |
|
| Registry Number | NCT02729571 |
| Clinical Trial Phase | Phase 1b |
| Clinical Trial Sponsor | Biofabri, S.L |
| Primary endpoint(s) for this clinical | Safety |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
_________________________ |
|
| Registry Number | NCT02013245 |
| Clinical Trial Phase | Phase 1a |
| Clnical Trial Sponsor | Biofabri, S.L |
| Primary endpoint(s) for this clinical | Safety |
| Target population(s) for clinical trial | Infants |
Related Publications
- Live attenuated TB vaccines representing the three modern Mycobacterium tuberculosis lineages reveal that the Euro–American genetic background confers optimal vaccine potential (EBioMedicine, 2020)
- Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled,double-blind dose-escalation trial (Lancet Respir Med, 2019)
- Reactogenicity to major tuberculosis antigens absent in BCG is linked to improved protection against Mycobacterium tuberculosis (Nat. Commun., 2017)
- Safety of human immunisation with a live-attenuated Mycobacterium tuberculosis vaccine: a randomised, double-blind, controlled phase I trial (Lancet Respir Med, 2015)
- Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials (Vaccine, 2013)