GamTBvac
Candidate Overview
GamTBvac is a recombinant vaccine containing three Mycobacterium tuberculosis (MTB) antigens: Ag85a and ESAT6-CFP10 fusion protein, fused with a dextran-binding domain (DBD) from Leuconostoc mesenteroides. These fusions are formulated with the adjuvant containing Dextran 500 kDa and DEAE-Dextran 500 kDa covered with CpG oligonucleotides.
Sponsor / Lead Developer: N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation
Clinical Trial Status: Active Trials
Primary Indication: Prevention of TB disease
Other Indication(s): Prevention of TB recurrence
Target Population(s): Adults
Clinical Trials
ACTIVE TRIALS |
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| Registry Number | NCT04975737 |
| Clinical Trial Phase | Phase 3 |
| Clinical Trial Sponsor | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
| Primary endpoint(s) for this clinical trial | Prevention of TB disease |
| Target population(s) for clinical trial | Adults |
| People without Mtb infection | |
COMPLETED TRIALS |
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| Registry Number | NCT03878004 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adults |
| People without Mtb infection | |
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| Registry Number | NCT03255278 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Target population(s) for clinical trial | People without Mtb infection |
Related Publications
- First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment (Vaccines, 2019)
- Multi-subunit BCG booster vaccineGamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models (PLOS ONE, 2017)
- Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study. (Vaccines (Basel), 2020)