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Open AccessArticle

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

1
N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, 123098 Moscow, Russia
2
National Medical Research Center for Physiopulmonology and Infectious Diseases, Ministry of Health of the Russian Federation, 127473 Moscow, Russia
3
The Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of Ministry of Healthcare of the Russian Federation (Sechenovskiy University), 119991 Moscow, Russia
4
Department of General and Clinical Pharmacology, RUDN University, 117198 Moscow, Russia
5
City Polyclinic No. 2, Moscow Department of Health, 117556 Moscow, Russia
6
Federal State Budgetary Educational Institution of Higher Education A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of the Russian Federation, 127473 Moscow, Russia
7
Infectious Clinical Hospital No. 2, 117556 Moscow, Russia
8
Department of Virology, Lomonosov Moscow State University, 119991 Moscow, Russia
*
Authors to whom correspondence should be addressed.
Vaccines 2020, 8(4), 652; https://doi.org/10.3390/vaccines8040652
Received: 9 September 2020 / Revised: 14 October 2020 / Accepted: 27 October 2020 / Published: 3 November 2020
(This article belongs to the Special Issue Evaluation of Vaccine Immunogenicity)
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 Mycobacterium tuberculosis (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. View Full-Text
Keywords: tuberculosis; subunit vaccine; BCG booster; clinical trials; safety and immunogenicity tuberculosis; subunit vaccine; BCG booster; clinical trials; safety and immunogenicity
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MDPI and ACS Style

Tkachuk, A.P.; Bykonia, E.N.; Popova, L.I.; Kleymenov, D.A.; Semashko, M.A.; Chulanov, V.P.; Fitilev, S.B.; Maksimov, S.L.; Smolyarchuk, E.A.; Manuylov, V.A.; Vasina, D.V.; Gushchin, V.A.; Gintsburg, A.L. 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, 8, 652. https://doi.org/10.3390/vaccines8040652

AMA Style

Tkachuk AP, Bykonia EN, Popova LI, Kleymenov DA, Semashko MA, Chulanov VP, Fitilev SB, Maksimov SL, Smolyarchuk EA, Manuylov VA, Vasina DV, Gushchin VA, Gintsburg AL. 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; 8(4):652. https://doi.org/10.3390/vaccines8040652

Chicago/Turabian Style

Tkachuk, Artem P.; Bykonia, Evgeniia N.; Popova, Liubov I.; Kleymenov, Denis A.; Semashko, Maria A.; Chulanov, Vladimir P.; Fitilev, Sergey B.; Maksimov, Semyon L.; Smolyarchuk, Elena A.; Manuylov, Victor A.; Vasina, Daria V.; Gushchin, Vladimir A.; Gintsburg, Alexander L. 2020. "Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study" Vaccines 8, no. 4: 652. https://doi.org/10.3390/vaccines8040652

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