Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies

The unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality papers describing clinical trials of different vacc...

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Main Authors: Liubov I. Kozlovskaya, Anastasia N. Piniaeva, Georgy M. Ignatyev, Ilya V. Gordeychuk, Viktor P. Volok, Yulia V. Rogova, Anna A. Shishova, Anastasia A. Kovpak, Yury Yu. Ivin, Liliya P. Antonova, Kirill M. Mefyod, Lyubov S. Prokosheva, Anna S. Sibirkina, Yuliya Yu. Tarasova, Ekaterina O. Bayurova, Olga S. Gancharova, Victoria V. Illarionova, Grigory S. Glukhov, Olga S. Sokolova, Konstantin V. Shaitan, Anastasia M. Moysenovich, Stanislav A. Gulyaev, Tatiana V. Gulyaeva, Andrey V. Moroz, Larissa V. Gmyl, Elena G. Ipatova, Mikhail P. Kirpichnikov, Alexey M. Egorov, Aleksandra A. Siniugina, Aydar A. Ishmukhametov
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Language:English
Published: Taylor & Francis Group 2021-01-01
Series:Emerging Microbes and Infections
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Online Access:https://www.tandfonline.com/doi/10.1080/22221751.2021.1971569
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author Liubov I. Kozlovskaya
Anastasia N. Piniaeva
Georgy M. Ignatyev
Ilya V. Gordeychuk
Viktor P. Volok
Yulia V. Rogova
Anna A. Shishova
Anastasia A. Kovpak
Yury Yu. Ivin
Liliya P. Antonova
Kirill M. Mefyod
Lyubov S. Prokosheva
Anna S. Sibirkina
Yuliya Yu. Tarasova
Ekaterina O. Bayurova
Olga S. Gancharova
Victoria V. Illarionova
Grigory S. Glukhov
Olga S. Sokolova
Konstantin V. Shaitan
Anastasia M. Moysenovich
Stanislav A. Gulyaev
Tatiana V. Gulyaeva
Andrey V. Moroz
Larissa V. Gmyl
Elena G. Ipatova
Mikhail P. Kirpichnikov
Alexey M. Egorov
Aleksandra A. Siniugina
Aydar A. Ishmukhametov
author_facet Liubov I. Kozlovskaya
Anastasia N. Piniaeva
Georgy M. Ignatyev
Ilya V. Gordeychuk
Viktor P. Volok
Yulia V. Rogova
Anna A. Shishova
Anastasia A. Kovpak
Yury Yu. Ivin
Liliya P. Antonova
Kirill M. Mefyod
Lyubov S. Prokosheva
Anna S. Sibirkina
Yuliya Yu. Tarasova
Ekaterina O. Bayurova
Olga S. Gancharova
Victoria V. Illarionova
Grigory S. Glukhov
Olga S. Sokolova
Konstantin V. Shaitan
Anastasia M. Moysenovich
Stanislav A. Gulyaev
Tatiana V. Gulyaeva
Andrey V. Moroz
Larissa V. Gmyl
Elena G. Ipatova
Mikhail P. Kirpichnikov
Alexey M. Egorov
Aleksandra A. Siniugina
Aydar A. Ishmukhametov
author_sort Liubov I. Kozlovskaya
collection DOAJ
description The unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality papers describing clinical trials of different vaccine products, basic detailed data on general toxicity, reproductive toxicity, immunogenicity, protective efficacy and durability of immune response in animal models are scarce. Here, we developed a β-propiolactone-inactivated whole virion vaccine CoviVac and assessed its safety, protective efficacy, immunogenicity and stability of the immune response in rodents and non-human primates. The vaccine showed no signs of acute/chronic, reproductive, embryo- and fetotoxicity, or teratogenic effects, as well as no allergenic properties in studied animal species. The vaccine induced stable and robust humoral immune response both in form of specific anti-SARS-CoV-2 IgG and NAbs in mice, Syrian hamsters, and common marmosets. The NAb levels did not decrease significantly over the course of one year. The course of two immunizations protected Syrian hamsters from severe pneumonia upon intranasal challenge with the live virus. Robustness of the vaccine manufacturing process was demonstrated as well. These data encouraged further evaluation of CoviVac in clinical trials.
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spelling doaj-art-25dd68ffe74e41b1a33bb195f59652722025-08-20T02:30:45ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512021-01-011011790180610.1080/22221751.2021.1971569Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studiesLiubov I. Kozlovskaya0Anastasia N. Piniaeva1Georgy M. Ignatyev2Ilya V. Gordeychuk3Viktor P. Volok4Yulia V. Rogova5Anna A. Shishova6Anastasia A. Kovpak7Yury Yu. Ivin8Liliya P. Antonova9Kirill M. Mefyod10Lyubov S. Prokosheva11Anna S. Sibirkina12Yuliya Yu. Tarasova13Ekaterina O. Bayurova14Olga S. Gancharova15Victoria V. Illarionova16Grigory S. Glukhov17Olga S. Sokolova18Konstantin V. Shaitan19Anastasia M. Moysenovich20Stanislav A. Gulyaev21Tatiana V. Gulyaeva22Andrey V. Moroz23Larissa V. Gmyl24Elena G. Ipatova25Mikhail P. Kirpichnikov26Alexey M. Egorov27Aleksandra A. Siniugina28Aydar A. Ishmukhametov29Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaDepartment of Biology, Lomonosov Moscow State University, Moscow, RussiaDepartment of Biology, Lomonosov Moscow State University, Moscow, RussiaDepartment of Biology, Lomonosov Moscow State University, Moscow, RussiaDepartment of Biology, Lomonosov Moscow State University, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaDepartment of Biology, Lomonosov Moscow State University, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Moscow, RussiaThe unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality papers describing clinical trials of different vaccine products, basic detailed data on general toxicity, reproductive toxicity, immunogenicity, protective efficacy and durability of immune response in animal models are scarce. Here, we developed a β-propiolactone-inactivated whole virion vaccine CoviVac and assessed its safety, protective efficacy, immunogenicity and stability of the immune response in rodents and non-human primates. The vaccine showed no signs of acute/chronic, reproductive, embryo- and fetotoxicity, or teratogenic effects, as well as no allergenic properties in studied animal species. The vaccine induced stable and robust humoral immune response both in form of specific anti-SARS-CoV-2 IgG and NAbs in mice, Syrian hamsters, and common marmosets. The NAb levels did not decrease significantly over the course of one year. The course of two immunizations protected Syrian hamsters from severe pneumonia upon intranasal challenge with the live virus. Robustness of the vaccine manufacturing process was demonstrated as well. These data encouraged further evaluation of CoviVac in clinical trials.https://www.tandfonline.com/doi/10.1080/22221751.2021.1971569VaccineSARS-CoV-2COVID-19neutralizing antibodiessafetyimmunogenicity
spellingShingle Liubov I. Kozlovskaya
Anastasia N. Piniaeva
Georgy M. Ignatyev
Ilya V. Gordeychuk
Viktor P. Volok
Yulia V. Rogova
Anna A. Shishova
Anastasia A. Kovpak
Yury Yu. Ivin
Liliya P. Antonova
Kirill M. Mefyod
Lyubov S. Prokosheva
Anna S. Sibirkina
Yuliya Yu. Tarasova
Ekaterina O. Bayurova
Olga S. Gancharova
Victoria V. Illarionova
Grigory S. Glukhov
Olga S. Sokolova
Konstantin V. Shaitan
Anastasia M. Moysenovich
Stanislav A. Gulyaev
Tatiana V. Gulyaeva
Andrey V. Moroz
Larissa V. Gmyl
Elena G. Ipatova
Mikhail P. Kirpichnikov
Alexey M. Egorov
Aleksandra A. Siniugina
Aydar A. Ishmukhametov
Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
Emerging Microbes and Infections
Vaccine
SARS-CoV-2
COVID-19
neutralizing antibodies
safety
immunogenicity
title Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
title_full Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
title_fullStr Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
title_full_unstemmed Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
title_short Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies
title_sort long term humoral immunogenicity safety and protective efficacy of inactivated vaccine against covid 19 covivac in preclinical studies
topic Vaccine
SARS-CoV-2
COVID-19
neutralizing antibodies
safety
immunogenicity
url https://www.tandfonline.com/doi/10.1080/22221751.2021.1971569
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