Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»

Objective of the work was the production of recombinant vaccine «RevaxVZT» in tablet dosage form against hepatitis B and pathogenic for humans orthopoxviruses for further clinical trials. Materials and methods. Recombinant strain b7.5S2-S of vaccinia virus carrying a DNA fragment of hepatitis B viru...

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Main Authors: A. I. Terent’ev, V. A. Zhukov, Ar. A. Sergeev, S. B. Pastushenko, S. V. Rоgоzhkina, S. V. Borisevich, V. A. Maksimov, Al. A. Sergeev, K. A. Titova, D. O. Galakhova
Format: Article
Language:Russian
Published: Federal Government Health Institution, Russian Research Anti-Plague Institute “Microbe” 2019-10-01
Series:Проблемы особо опасных инфекций
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Online Access:https://journal.microbe.ru/jour/article/view/1180
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author A. I. Terent’ev
V. A. Zhukov
Ar. A. Sergeev
S. B. Pastushenko
S. V. Rоgоzhkina
S. V. Borisevich
V. A. Maksimov
Al. A. Sergeev
K. A. Titova
D. O. Galakhova
author_facet A. I. Terent’ev
V. A. Zhukov
Ar. A. Sergeev
S. B. Pastushenko
S. V. Rоgоzhkina
S. V. Borisevich
V. A. Maksimov
Al. A. Sergeev
K. A. Titova
D. O. Galakhova
author_sort A. I. Terent’ev
collection DOAJ
description Objective of the work was the production of recombinant vaccine «RevaxVZT» in tablet dosage form against hepatitis B and pathogenic for humans orthopoxviruses for further clinical trials. Materials and methods. Recombinant strain b7.5S2-S of vaccinia virus carrying a DNA fragment of hepatitis B virus inserted into thymidinekinase gene was used as an active component of the vaccine. Microbiological, virological, physical, physical and chemical, and biotechnological methods were used for studying the quality of the drug and technological processes. Results and discussion. Results of technological control for semi-finished products and final products of the vaccine “Revax VZT” showed the possibility of using certified hardware-processing line of “TEOVac” for its manufacturing. Same technology can be potentially used with other live tableted embryo smallpox vaccines too. For the development of the vaccine “Revax VZT” with the specific activity of not less than 1.0·107 PFu/tablet, it is necessary to use a dry virus-containing material with activity not less than 2.0·108 PFU/g which is produced by freeze-drying of liquid virus-containing preparation with the activity of not less than 1.0·108 PFU/g, preferentially propagated from chorionic allantoic membranes of chicken embryos as a substrate for viral biomass accumulation.
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spelling doaj.art-82caec297f4545c59d859c44a9ba13622024-04-05T16:47:14ZrusFederal Government Health Institution, Russian Research Anti-Plague Institute “Microbe”Проблемы особо опасных инфекций0370-10692658-719X2019-10-0103949910.21055/0370-1069-2019-3-94-991140Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»A. I. Terent’ev0V. A. Zhukov1Ar. A. Sergeev2S. B. Pastushenko3S. V. Rоgоzhkina4S. V. Borisevich5V. A. Maksimov6Al. A. Sergeev7K. A. Titova8D. O. Galakhova948th Central Research Institute of the Ministry of Defense of the Russian Federation48th Central Research Institute of the Ministry of Defense of the Russian FederationState Scientific Center of Virology and Biotechnology «Vector»48th Central Research Institute of the Ministry of Defense of the Russian Federation48th Central Research Institute of the Ministry of Defense of the Russian Federation48th Central Research Institute of the Ministry of Defense of the Russian Federation48th Central Research Institute of the Ministry of Defense of the Russian FederationState Scientific Center of Virology and Biotechnology «Vector»State Scientific Center of Virology and Biotechnology «Vector»State Scientific Center of Virology and Biotechnology «Vector»Objective of the work was the production of recombinant vaccine «RevaxVZT» in tablet dosage form against hepatitis B and pathogenic for humans orthopoxviruses for further clinical trials. Materials and methods. Recombinant strain b7.5S2-S of vaccinia virus carrying a DNA fragment of hepatitis B virus inserted into thymidinekinase gene was used as an active component of the vaccine. Microbiological, virological, physical, physical and chemical, and biotechnological methods were used for studying the quality of the drug and technological processes. Results and discussion. Results of technological control for semi-finished products and final products of the vaccine “Revax VZT” showed the possibility of using certified hardware-processing line of “TEOVac” for its manufacturing. Same technology can be potentially used with other live tableted embryo smallpox vaccines too. For the development of the vaccine “Revax VZT” with the specific activity of not less than 1.0·107 PFu/tablet, it is necessary to use a dry virus-containing material with activity not less than 2.0·108 PFU/g which is produced by freeze-drying of liquid virus-containing preparation with the activity of not less than 1.0·108 PFU/g, preferentially propagated from chorionic allantoic membranes of chicken embryos as a substrate for viral biomass accumulation.https://journal.microbe.ru/jour/article/view/1180recombinant strain of vaccinia virushepatitis вorthopoxviruses pathogenic for humanssmallpox vaccine in tabletstechnologyhardware-processing line
spellingShingle A. I. Terent’ev
V. A. Zhukov
Ar. A. Sergeev
S. B. Pastushenko
S. V. Rоgоzhkina
S. V. Borisevich
V. A. Maksimov
Al. A. Sergeev
K. A. Titova
D. O. Galakhova
Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
Проблемы особо опасных инфекций
recombinant strain of vaccinia virus
hepatitis в
orthopoxviruses pathogenic for humans
smallpox vaccine in tablets
technology
hardware-processing line
title Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
title_full Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
title_fullStr Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
title_full_unstemmed Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
title_short Experience in the Design and Production of Recombinant Oral Vaccine «Revax VZT»
title_sort experience in the design and production of recombinant oral vaccine revax vzt
topic recombinant strain of vaccinia virus
hepatitis в
orthopoxviruses pathogenic for humans
smallpox vaccine in tablets
technology
hardware-processing line
url https://journal.microbe.ru/jour/article/view/1180
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