Toxicity Evaluation of a VLP-Based Vaccine Аgainst Human Rotavirus Infection Following a Single Administration in Rats: Serum Biochemistry and Histopathological Examination of Organs and Injection Site

Authors

  • Oleg V. Ledenev Department of Biology, Lomonosov Moscow State University, Leninskie Gory, 119234 Moscow, Russia https://orcid.org/0009-0008-6772-1298
  • Ilya E. Filatov National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia https://orcid.org/0000-0001-5274-224X
  • Olesya V. Eliseeva National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia https://orcid.org/0000-0002-0723-9749
  • Oleg E. Latyshev National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia https://orcid.org/0000-0003-1934-9635
  • Igor A. Dyachenko Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0000-0002-3053-2804
  • Gulsara A. Slashcheva Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0000-0002-4422-487X
  • Elvira R. Shaykhutdinova Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0000-0003-2768-4978
  • Ekaterina N. Kazakova Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0009-0002-4885-1069
  • Elena S. Sadovnikova Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0000-0002-5193-4343
  • Olga I. Patsap Scientific and Educational Resource Center for Innovative Technologies of Immunophenotyping, Digital Spatial Profiling and Ultrastructural Analysis (Molecular Morphology), Peoples' Friendship University of Russia, Moscow, str. Miklukho-Maklaya, 6 https://orcid.org/0000-0003-4620-3922
  • Varvara V. Lebedeva National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia https://orcid.org/0000-0002-3088-0403
  • Arkady N. Murashev Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia https://orcid.org/0000-0002-2279-9285
  • Tatiana V. Grebennikova National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia https://orcid.org/0000-0002-6141-9361

Abstract

Virus-like particle (VLP) - based vaccines exhibit outstanding clinical, epidemiological, and immunological efficacy and specificity. The novel technology used for producing their active component without incorporating live viruses enables both injectable and non-injectable (e.g., intranasal) administration, emphasizing the need for a comprehensive safety assessment. This study is part of a preclinical toxicological evaluation program aimed at assessing the safety profile of the “Gam-VLP-rota” vaccine candidate targeting human rotavirus infection.

The goal of this extended toxicology study was to confirm the safety of a single intramuscular administration of the vaccine in Sprague-Dawley rats. The study focused on identifying possible adverse effects both acutely (within 24 hours post-administration) and after a 14-day recovery period, aiming to detect delayed toxicological signs. Toxicological endpoints included evaluation of target organs, coagulation parameters, hematology, clinical biochemistry, necropsy findings, and histopathological analysis.

This article presents a segment of the results, including changes in serum biochemical parameters after a single immunization and histological examination of internal organs and the injection site in rats.

Keywords: VLP; vaccines; preclinical studies; vaccine safety; toxicological chemistry.

Keywords:

VLP, vaccines, preclinical studies, vaccine safety, toxicological chemistry

DOI

https://doi.org/10.22270/jddt.v15i8.7314

Author Biographies

Oleg V. Ledenev , Department of Biology, Lomonosov Moscow State University, Leninskie Gory, 119234 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

Ilya E. Filatov , National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

Olesya V. Eliseeva , National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

Oleg E. Latyshev , National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

Igor A. Dyachenko , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Gulsara A. Slashcheva , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Elvira R. Shaykhutdinova , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Ekaterina N. Kazakova , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

 

Elena S. Sadovnikova , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Olga I. Patsap , Scientific and Educational Resource Center for Innovative Technologies of Immunophenotyping, Digital Spatial Profiling and Ultrastructural Analysis (Molecular Morphology), Peoples' Friendship University of Russia, Moscow, str. Miklukho-Maklaya, 6

Scientific and Educational Resource Center for Innovative Technologies of Immunophenotyping, Digital Spatial Profiling and Ultrastructural Analysis (Molecular Morphology), Peoples' Friendship University of Russia, Moscow, str. Miklukho-Maklaya, 6

Varvara V. Lebedeva , National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

Arkady N. Murashev , Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Branch of the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 6 Nauki Avenue, 142290 Pushchino, Russia

Tatiana V. Grebennikova , National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia

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Published

2025-08-15
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How to Cite

1.
Ledenev OV, Filatov IE, Eliseeva OV, Latyshev OE, Dyachenko IA, Slashcheva GA, et al. Toxicity Evaluation of a VLP-Based Vaccine Аgainst Human Rotavirus Infection Following a Single Administration in Rats: Serum Biochemistry and Histopathological Examination of Organs and Injection Site. J. Drug Delivery Ther. [Internet]. 2025 Aug. 15 [cited 2026 Apr. 18];15(8):69-7. Available from: https://jddtonline.info/index.php/jddt/article/view/7314

Issue

Vol. 15 No. 8 (2025): Volume 15, Issue 8, August 2025

Section

Research

Copyright (c) 2025 Oleg V. Ledenev , Ilya E. Filatov , Olesya V. Eliseeva , Oleg E. Latyshev , Igor A. Dyachenko , Gulsara A. Slashcheva , Elvira R. Shaykhutdinova , Ekaterina N. Kazakova , Elena S. Sadovnikova , Olga I. Patsap , Varvara V. Lebedeva , Arkady N. Murashev , Tatiana V. Grebennikova

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How to Cite

1.
Ledenev OV, Filatov IE, Eliseeva OV, Latyshev OE, Dyachenko IA, Slashcheva GA, et al. Toxicity Evaluation of a VLP-Based Vaccine Аgainst Human Rotavirus Infection Following a Single Administration in Rats: Serum Biochemistry and Histopathological Examination of Organs and Injection Site. J. Drug Delivery Ther. [Internet]. 2025 Aug. 15 [cited 2026 Apr. 18];15(8):69-7. Available from: https://jddtonline.info/index.php/jddt/article/view/7314
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