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Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study. | LitMetric

AI Article Synopsis

  • GamTBvac is a candidate tuberculosis vaccine made of fusion proteins and aims to evaluate safety and immune response.
  • A Phase II study involved 180 healthy volunteers who received either GamTBvac or a placebo to assess its effects over multiple timepoints.
  • The results showed that GamTBvac had a good safety profile and effectively induced immune responses, supporting the need for further clinical testing.

Article Abstract

GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette-Guérin vaccine (BCG) healthy volunteers without (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4 T-cells, and IgG responses and results support further clinical testing of GamTBvac.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712213PMC
http://dx.doi.org/10.3390/vaccines8040652DOI Listing

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