Copyright: © 2018 by the authors. Licensee: Pirogov University.
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ORIGINAL RESEARCH

Immunological memory formed in response to administration of GamTBvac recombinant tuberculosis vaccine candidate: clinical trials in healthy volunteers

About authors

1 Laboratory of Translational Biomedicine,
N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Moscow, Russia

2 Institute of Molecular Medicine,
I. M. Sechenov First Moscow State Medical University, Moscow, Russia

3 Department of Virology, Faculty of Biology,
Lomonosov Moscow State University, Moscow

Correspondence should be addressed: Denis A. Kleymenov
ul. Gamalei, d. 18, Moscow, Russia, 123098; ur.relbmar@tel00001

About paper

Funding: this work was supported by the Russian Ministry of Health and the Federal Agency for Scientific Organizations (state task no. 0574-2014-0023)

Contribution of the authors to this work: Kleymenov DA — analysis of literature, research planning, research preparation, data collection, analysis, and interpreatation, drafting of a manuscript, writing of a final version of a manuscript; Mazunina EP — analysis of literature, research planning, research preparation, data collection, analysis, and interpretation, drafting of a manuscript; Lunin VG — analysis of literature, research planning, research preparation, drafting of a manuscript; Koptev EYu, Manuilov VA — analysis of literature, research preparation, drafting of a manuscript; Gushchin VA — analysis of literature, research planning, research preparation, data analysis and interpretation, drafting of a manuscript, writing of a final version of a manuscript; Tkachuk AP — analysis of literature, research planning, research preparation, drafting of a manuscript, critical analysis of a manuscript.

Received: 2017-09-20 Accepted: 2017-10-20 Published online: 2018-01-13
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Fig. 1. The schematic of the study design. Stages 1 and 2 of the study reported in this article are shown in bold
Fig. 2. Immunogenicity of the GamTBvac vaccine in 12 volunteers. (A), (B) Evaluation of cell-mediated immunity. For the analysis we employed a modification of IGRA [19] that measures INFγ secretion by whole blood lymphocytes in response to stimulation with antigens DBD-Ag85A (А) and DBD-ESAT6-CFP10 (B). The value of spontaneous IFNγ secretion was subtracted from the raw value. (C)–(H) xMAP-based quantification of antibodies to the antigen fusion (C) and its components: CFP10 (D), ESAT6 (E), DBD (F), and DBD-Ag85A (G) and its main component Ag85A (H). Statistical significance was calculated using the Wilcoxon matched-pairs test. Significant differences over the observation period (*р < 0.05 and **р < 0.01) are shown in green, in comparison with day 0. Red p-values indicate the absence of significant differences. Vaccination days are represented by blue arrows
Concentrations of antigens used for coupling to microspheres