Email this article Study of immunogenicity and safety of a candidate rotavirus vaccine based on a recombinant hybrid protein
- Authors: Varyushina E.A.1, Alexandrov G.V.1, Zakharov M.S.1, Kiryanova A.S.1, Huttunen O.E.1, Rumyantseva A.B.1, Mitrofanov I.D.1, Bendt I.V.1, Krylova A.E.1, Chistyakova A.B.1, Artemova N.A.1, Shatillo I.M.2, Bogomolova E.G.1, Dobrovolskaya O.A.1, Ischuk S.A.1, Dukhovlinov I.V.1, Simbirtsev A.S.1
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Affiliations:
- State Research Institute of Highly Pure Biopreparations
- North-West State Medical University named after I.I. Mechnikov
- Issue: Vol 21, No 2 (2021)
- Pages: 87-98
- Section: Original research
- URL: https://bakhtiniada.ru/MAJ/article/view/71134
- DOI: https://doi.org/10.17816/MAJ71134
- ID: 71134
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Abstract
BACKGROUND: Rotaviruses are the main cause of acute gastroenteritis in children in both developed and developing countries. Vaccination is the only way to prevent severe and fatal course of this disease. Live attenuated viruses-based vaccines currently available can have a number of side effects. A candidate rotavirus vaccine reported is based on a hybrid recombinant protein FliCVP6VP8, which includes a VP6 protein fragment, a rotavirus A VP8 protein fragment, and S. typhimurium FliC flagellin components.
AIM: The aim was to evaluate the immunogenicity and safety of а preparation “Rotavirus vaccine, recombinant” in preclinical studies.
MATERIALS AND METHODS: The immunogenicity of vaccine (blood antibody titers, antigen-specific proliferative response of spleen cells) was evaluated in BALB/c mice. The acute and subchronic toxicity, the possible irritating effect, pyrogenicity and the anaphylactic effect and delayed type hypersensitivity were evaluated in laboratory mice, rats, Guinea pigs, and rabbits.
RESULTS: Double immunization of mice with the candidate vaccine demonstrated a significant increase in antibody titers in mouse sera compared to that in control mice. Evaluation of antigen-specific proliferative response after double immunization with a candidate vaccine demonstrated a significant increase in the values of stimulated proliferation. Evaluation of safety through acute and chronic toxicity studies demonstrated no toxicity. The immunostimulatory effect of vaccine was demonstrated when evaluating the number of antibody-producing cells with sheep red blood cells as antigens. The number of white blood cells was demonstrated to increase after the prolonged vaccine administration.
CONCLUSIONS: The preclinical studies have demonstrated safety of the candidate rotavirus vaccine and its capability to produce the immune response.
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##article.viewOnOriginalSite##About the authors
Elena A. Varyushina
State Research Institute of Highly Pure Biopreparations
Author for correspondence.
Email: elenavaryush@gmail.com
Dr. Sci. (Biology), Leading Biotechnologist, Protein Biochemistry Laboratory
Russian Federation, Saint PetersburgGeorgy V. Alexandrov
State Research Institute of Highly Pure Biopreparations
Email: g.v.aleksandrov@hpb.spb.ru
PhD, Deputy Head, Department of Preclinical Research
Russian Federation, Saint PetersburgMikhail S. Zakharov
State Research Institute of Highly Pure Biopreparations
Email: m.s.zakharov@hpb.spb.ru
сonsultant, Department of Preclinical Research
Russian Federation, Saint PetersburgAnna S. Kiryanova
State Research Institute of Highly Pure Biopreparations
Email: a.s.kirianova@hpb.spb.ru
Quality Specialist, Quality Assurance Department
Russian Federation, Saint PetersburgOlga E. Huttunen
State Research Institute of Highly Pure Biopreparations
Email: o.e.khuttunen@hpb.spb.ru
biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgAlina B. Rumyantseva
State Research Institute of Highly Pure Biopreparations
Email: a.b.rumyantseva@hpb.spb.ru
Senior Biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgIlya D. Mitrofanov
State Research Institute of Highly Pure Biopreparations
Email: i.d.mitrofanov@hpb.spb.ru
biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgIrina V. Bendt
State Research Institute of Highly Pure Biopreparations
Email: i.v.bendt@hpb.spb.ru
Senior Biotechnologist, Department of Preclinical Research
Russian Federation, Saint PetersburgAnna E. Krylova
State Research Institute of Highly Pure Biopreparations
Email: a.e.polyanskaya@hpb.spb.ru
biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgAnastasia B. Chistyakova
State Research Institute of Highly Pure Biopreparations
Email: a.b.chistyakova@hpb.spb.ru
biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgNatalya A. Artemova
State Research Institute of Highly Pure Biopreparations
Email: n.a.artemova@hpb.spb.ru
Senior Biologist, Department of Preclinical Research
Russian Federation, Saint PetersburgIrina M. Shatillo
North-West State Medical University named after I.I. Mechnikov
Email: elenavaryush@gmail.com
MD, PhD, Associate Professor of the Department of Pediatrics with a course in Neonatology
Russian Federation, Saint PetersburgElena G. Bogomolova
State Research Institute of Highly Pure Biopreparations
Email: bogomolovaele@inbox.ru
Deputy Head of the Laboratory for Vaccine Genetic Engineering
Russian Federation, Saint PetersburgOlga A. Dobrovolskaya
State Research Institute of Highly Pure Biopreparations
Email: bogomolovaele@inbox.ru
Junior Researcher, Laboratory for Genetic Engineering of Vaccines
Russian Federation, Saint PetersburgSergey A. Ischuk
State Research Institute of Highly Pure Biopreparations
Email: bogomolovaele@inbox.ru
Junior Researcher, Laboratory for Genetic Engineering of Vaccines
Russian Federation, Saint PetersburgIlya V. Dukhovlinov
State Research Institute of Highly Pure Biopreparations
Email: bogomolovaele@inbox.ru
PhD, Head of the Laboratory for Genetic Engineering of Vaccines
Russian Federation, Saint PetersburgAndrey S. Simbirtsev
State Research Institute of Highly Pure Biopreparations
Email: a.s.simbirtsev@hpb.spb.ru
Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Sciences, Chief Researcher of the Protein Biochemistry Laboratory
Russian Federation, Saint PetersburgReferences
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