Effect of inactivated whole-virion concentrated purified vaccine for the prevention of COVID-19 on clinical and biochemical blood parameters of immature rats

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Abstract

Introduction. The prevalence of new coronavirus infection (COVID-19) in 2021-2022 in the pediatric population was 9.5%, and fatal outcomes began to be recorded. In 2022–2023, the proportion of children infected with COVID-19 increased to 18%. Developing a vaccine for the pediatric population is an urgent task.

The aim of the study is to explore the effect of the vaccine on the parameters of general and biochemical blood tests in immature rats.

Materials and methods. The study was performed on 112 immature rats (60 females, 52 males) of the Wistar line. Animals were randomized into groups that received the CoviVac vaccine at doses of 0.125, 0.25 and 0.5 mL/animal or placebo (0.5 mL/animal), intramuscularly on days 1, 15, 29 and 43 of the experiment. General and biochemical blood tests were performed twice, on the 57th and 71st days.

Results. Oligocythemia (0.25 and 0.5 mL/animal, p < 0.05), leukocytosis and thrombocytopenia (0.5 mL/animal, p < 0.05) were recorded in males. Monocytopenia (0.5 mL/animal, p < 0.05) and leukopenia (0.25 mL/animal, p < 0.05) were established in females. In males, an increase in the amount of globulins and total protein (0.5 mL/animal), a decrease in the A/G ratio (doses 0.25 and 0.5 mL/animal), a decrease in the cholesterol level (0.125 mL/animal) were detected. In females, an increase in the amount of albumin and total protein (0.5 mL/animal, p < 0.05), a decrease in the level of triglycerides (0.125, 0.25, 0.5 mL/animal, placebo, p < 0.05), a decrease in the level of lactate dehydrogenase, triglycerides and urea (0.25 mL/animal, p < 0.05) were recorded.

Conclusion. The safety of the CociVac vaccine in relation to clinical and biochemical blood parameters has been demonstrated.

About the authors

Aleksandra A. Siniugina

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: sinyugina@chumakovs.su
ORCID iD: 0000-0002-7251-6570

Cand. Sci. (Med.), Head of Quality and Innovation Development 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Natalya A. Lycheva

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Author for correspondence.
Email: Lycheva_na@chumakovs.su
ORCID iD: 0000-0002-5842-5728

Cand. Sci. (Biol.), Deputy Head of the Department for Preclinical Research 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Anastasia A. Saprykina

Research-and-manufacturing company «HOME OF PHARMACY» Joint Stock company

Email: saprykina.aa@doclinika.ru
ORCID iD: 0000-0002-7588-3982

Junior Research Fellow

Russian Federation, 188663, urban settlement Kuzmolovsky, Vsevolozhsky district, Leningrad region

Kirill L. Kryshen’

Research-and-manufacturing company «HOME OF PHARMACY» Joint Stock company

Email: kryshen.kl@doclinika.ru
ORCID iD: 0000-0003-1451-7716

Cand. Sci. (Biol.), Head of the Department of Specific Toxicology and Microbiology 

Russian Federation, 188663, urban settlement Kuzmolovsky, Vsevolozhsky district, Leningrad region

Vasiliy D. Apolokhov

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: apolohov_vd@chumakovs.su
ORCID iD: 0000-0002-9978-222X

Researcher

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Anastasiya D. Chernavtseva

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: chernavtseva_ad@chumakovs.su
ORCID iD: 0009-0009-6232-7512

Virologist of the department of preclinical studies and diagnostic drugs 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Anastasiya A. Kovpak

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: kovpak_aa@chumakovs.su
ORCID iD: 0000-0003-3200-763X

Head of the group of purification processes and formulation of finished dosage forms 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Yuriy Yu. Ivin

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: ivin_uu@chumakovs.su
ORCID iD: 0000-0003-0995-7944

Head of the Department for Development and Implementation of Innovative and Semi-Industrial Technologies 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Anastasia N. Piniaeva

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: pinyaeva_an@chumakovs.su
ORCID iD: 0000-0001-5381-2393

Cand. Sci. (Biol.), Chief technologist 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

Marina N. Makarova

Research-and-manufacturing company «HOME OF PHARMACY» Joint Stock company

Email: makarova.mn@doclinika.ru
ORCID iD: 0000-0003-3176-6386

D. Sci. (Med.), Director 

Russian Federation, 188663, urban settlement Kuzmolovsky, Vsevolozhsky district, Leningrad region

Valery G. Makarov

Research-and-manufacturing company «HOME OF PHARMACY» Joint Stock company

Email: makarov.vg@doclinika.ru
ORCID iD: 0000-0002-2447-7888

D. Sci. (Med.), Scientific supervisor 

Russian Federation, 188663, urban settlement Kuzmolovsky, Vsevolozhsky district, Leningrad region

Aidar A. Ishmukhametov

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis), Village of Institute of Poliomyelitis

Email: ishmukhametov@chumakovs.su
ORCID iD: 0000-0001-6130-4145

D. Sci. (Med.), Prof., Academician of the Russian Academy of Sciences,General manager 

Russian Federation, Settlement Moskovskiy, 108819, Moscow

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Copyright (c) 2025 Siniugina A.A., Lycheva N.A., Saprykina A.A., Kryshen’ K.L., Apolokhov V.D., Chernavtseva A.D., Kovpak A.A., Ivin Y.Y., Piniaeva A.N., Makarova M.N., Makarov V.G., Ishmukhametov A.A.

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