Drug intelligence / Profile preview

GamTBvac

Development stage
Phase 3
Lead developer
Gamaleya Center
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

**GamTBvac** is an investigational recombinant protein-subunit vaccine developed as a Bacillus Calmette-Guérin booster and preventive vaccine against tuberculosis. It contains recombinant *Mycobacterium tuberculosis* antigen components based on Ag85A and an ESAT-6–CFP-10 fusion, each linked to a dextran-binding domain, and is formulated with a dextran/DEAE-dextran-associated CpG oligodeoxynucleotide adjuvant. The antigen components are intended to elicit protective antigen-specific cellular and humoral immunity, while CpG activates innate immune signaling through Toll-like receptor 9. Clinical studies have reported induction of antigen-specific interferon-gamma release, Th1-type CD4-positive T-cell responses, and IgG responses. GamTBvac has completed Phase 1 and Phase 2 safety/immunogenicity studies and is in a Phase 3 placebo-controlled study for prevention of active non-HIV-associated pulmonary tuberculosis and tuberculosis recurrence. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC6963980/))

Other names
Double GamTBvac
02

Targets

TLR9 (Toll-like receptor 9)Ag85A (Antigen 85A)CFP-10 (Culture filtrate protein 10)ESAT-6 (Early secretory antigenic target 6)

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