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

被引：50

作者：

Kozlovskaya, Liubov, I ^{[1
,2
]}

Piniaeva, Anastasia N. ^{[1
]}

Ignatyev, Georgy M. ^{[1
]}

Gordeychuk, Ilya, V ^{[1
,2
]}

Volok, Viktor P. ^{[1
,3
]}

Rogova, Yulia, V ^{[1
]}

Shishova, Anna A. ^{[1
,2
]}

Kovpak, Anastasia A. ^{[1
]}

Ivin, Yury Yu ^{[1
]}

Antonova, Liliya P. ^{[1
]}

Mefyod, Kirill M. ^{[1
]}

Prokosheva, Lyubov S. ^{[1
]}

Sibirkina, Anna S. ^{[1
]}

Tarasova, Yuliya Yu ^{[1
]}

Bayurova, Ekaterina O. ^{[1
]}

Gancharova, Olga S. ^{[1
]}

Illarionova, Victoria V. ^{[1
]}

Glukhov, Grigory S. ^{[3
]}

Sokolova, Olga S. ^{[3
]}

Shaitan, Konstantin, V ^{[3
]}

Moysenovich, Anastasia M. ^{[3
]}

Gulyaev, Stanislav A. ^{[1
]}

Gulyaeva, Tatiana, V ^{[1
]}

Moroz, Andrey, V ^{[1
]}

Gmyl, Larissa, V ^{[1
]}

Ipatova, Elena G. ^{[1
]}

Kirpichnikov, Mikhail P. ^{[3
]}

Egorov, Alexey M. ^{[1
,3
]}

Siniugina, Aleksandra A. ^{[1
]}

Ishmukhametov, Aydar A. ^{[1
,2
]}

机构：

[1] Russian Acad Sci, Chumakov Fed Sci Ctr Res & Dev Immune & Biol Prod, Moscow 108819, Russia

[2] Sechenov First Moscow State Med Univ, Inst Translat Med & Biotechnol, Moscow 127994, Russia

[3] Lomonosov Moscow State Univ, Dept Biol, Moscow, Russia

来源：

EMERGING MICROBES & INFECTIONS | 2021年 / 10卷 / 01期

关键词：

Vaccine; SARS-CoV-2; COVID-19; neutralizing antibodies; safety; immunogenicity; inactivated vaccine; preclinical study; SARS-COV-2; INFECTION;

D O I：

10.1080/22221751.2021.1971569

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 beta-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.

引用

页码：1790 / 1806

页数：17

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