GamTBvac

Phase of Development

Phase 3

Vaccine Platform

Protein / Adjuvant

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
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
Target population(s) for clinical trial	People without Mtb infection
COMPLETED TRIALS
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
Primary endpoint(s) for this clinical trial	Immunogenicity
Target population(s) for clinical trial	Adults
Target population(s) for clinical trial	People without Mtb infection
Results/Publication	Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study (Vaccines, 2020)
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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
Results/Publication	First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment (Vaccines, 2019)