ISSN Print 2500–1094
ISSN Online 2542–1204
BIOMEDICAL JOURNAL OF PIROGOV UNIVERSITY (MOSCOW, RUSSIA)
ORIGINAL RESEARCH
The candidate anti-tuberculosis mRNA vaccine immunogenicity and reactogenicity dependency on the animal’s sex and the vaccine dose
About authors
1 Sirius University of Science and Technology, Sirius, Russia
2 Central Tuberculosis Research Institute, Moscow, Russia
3 National Research Centre "Kurchatov Institute", Moscow, Russia
Correspondence should be addressed: Vasily V. Reshetnikov
Olimpiysky prospekt, 1, Sochi, 354340, Russia; ur.hepsuitnalat@vv.vokintehser
About paper
Funding: the study was supported by the Ministry of Science and Higher Education of the Russian Federation (agreement No. 075-10-2021-113, project ID RF----193021X0001).
Acknowledgements: the authors express their gratitude to staff members of the Sirius University of Science and Technology: I. M. Terenin for in vitro transcription, O. V. Zaborova for formulation of mRNA into lipid nanoparticles.
Author contribution: Reshetnikov VV — mRNA vaccine preparation, experimental procedure, manuscript writing; Shepelkova GS — experimental procedure, data analysis; Rybakova AV — experimental procedure, data analysis; Trashkov AP — planning the experiment, manuscript editing; Yeremeev VV — planning the experiment, manuscript editing; Ivanov RA — planning the experiment, manuscript editing.
Compliance with ethical standards: the study was approved by the Ethics Committee of the National Research Centre "Kurchatov Institute" (protocol No. 2 dated 31 October 2023) and conducted in accordance with the Order of the Ministry of Health No. 755 and the Guidelines issued by the Office of Laboratory Animal Welfare (А5502-01).
Received: 2024-09-16
Accepted: 2024-10-04
Published online: 2024-10-30
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mRNA vaccines turned out to be highly effective in combating the COVID-19 pandemic and other viral infections. Despite extensive study of mRNA vaccines in the last five years, the issue of safety of their use is still relevant. The study aimed to assess immunogenicity of two anti-tuberculosis mRNA vaccine doses in female and male rats 2 and 4 weeks after vaccination. Hematological and biochemical parameters of blood were determined within the same timeframe. The dose-dependent nature of mRNA vaccine immunogenicity was confirmed in both females and males. Vaccination led to moderate lymphopenia and neutrophilia in male rats, as well as to apparent dose-dependent and sex-related changes in blood biochemistry parameters at various time points. The findings suggest moderate toxicity of the anti-tuberculosis mRNA vaccine and the importance of assessing its toxic effects at various time points in animals of both sexes.
Keywords: tuberculosis, toxicity, mRNA vaccine, immunogenicity