Nonclinical safety and biodistribution evaluation of HC009 mRNA vaccine against COVID-19 in rat

IF 4.8 3区医学 Q1 PHARMACOLOGY & PHARMACY

Toxicology Pub Date : 2025-03-08 DOI:10.1016/j.tox.2025.154107

Juan Liu, Xicheng Chen, Chuanqian Chen, Jie Wu, Fengyang Xie, Jing Li, Huafeng Han, Yingying Zhao, Yongsheng Yang

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引用次数: 0

Abstract

mRNA-based technology has been evaluated in clinical trials for rapid control and prevention of emergencies and diseases. HC009, a mRNA vaccine encoding the full-length SARS-CoV-2 spike protein delivered via the QTsome platform, was tested in rats for immunogenicity, toxicity, and biodistribution. For immunogenicity and toxicity, rats received three intramuscular injections of HC009 at 3-week intervals followed by a 4-week observation period. In the biodistribution study, rats received a single intramuscular injection, with mRNA levels measured in organs at various time points. Results showed that HC009 elicited effective, long-lasting humoral immunity and Th1-biased cellular responses. The mRNA primarily localized to the injection site and spleen, with no observed vaccine-related toxicological reactions. These findings support HC009’s potential for inducing an effective immune response with a favorable safety profile, warranting further clinical investigation.

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来源期刊

Toxicology 医学-毒理学

CiteScore

7.80

自引率

4.40%

发文量

222

审稿时长

23 days

期刊介绍： Toxicology is an international, peer-reviewed journal that publishes only the highest quality original scientific research and critical reviews describing hypothesis-based investigations into mechanisms of toxicity associated with exposures to xenobiotic chemicals, particularly as it relates to human health. In this respect "mechanisms" is defined on both the macro (e.g. physiological, biological, kinetic, species, sex, etc.) and molecular (genomic, transcriptomic, metabolic, etc.) scale. Emphasis is placed on findings that identify novel hazards and that can be extrapolated to exposures and mechanisms that are relevant to estimating human risk. Toxicology also publishes brief communications, personal commentaries and opinion articles, as well as concise expert reviews on contemporary topics. All research and review articles published in Toxicology are subject to rigorous peer review. Authors are asked to contact the Editor-in-Chief prior to submitting review articles or commentaries for consideration for publication in Toxicology.