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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Abstract

mRNA-based technology has been evaluated in a variety of clinical trials for the rapid control and prevention of emergencies and therapeutic indications. HC009 is a mRNA-based vaccine encoding the full-length of the SARS-CoV-2 spike protein and delivered by the QTsome delivery platform. Here, the immunogenicity, toxicity, and biodistribution of HC009 were investigated in rats. In the immunogenicity and toxicity study, rats received three intramuscular (IM) injections of HC009 at a 3-week interval followed by a 4-week observation period. In the biodistribution study, rats were given a single intramuscular injection of HC009, and the amount of the mRNA was detected in the organs and at various time points. The study results showed that HC009 could elicit effective and long-lasting humoral immunity and Th1-biased cellular responses. The mRNA of HC009 was mainly distributed in the injection site and the spleen, and no vaccine-related toxicological reaction was observed. Together, these data have shown that HC009 could induce an effective immune response with a favorable safety profile and support its further study in clinical trials.

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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.