Tonix Pharmaceutical, Frederick, MD 21701, USA.
Southern Research, Birmingham, AL 35205, USA.
Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131.
TNX-1800 is a preclinical stage synthetic-derived live attenuated chimeric horsepox virus vaccine engineered to express the SARS-CoV-2 spike (S) gene. The objectives of this study were to assess the safety, tolerability, and immunogenicity of TNX-1800 administration in Syrian golden hamsters and New Zealand white rabbits. Animals were vaccinated at three doses via percutaneous inoculation. The data showed that the single percutaneous administration of three TNX-1800 vaccine dose levels was well tolerated in both hamsters and rabbits. At all dose levels, rabbits were more decerning regarding vaccine site reaction than hamsters. Lastly, no TNX-1800 genomes could be detected at the site of vaccination. Post-vaccination, all animals had anti-SARS-CoV-2 spike protein IgG specific antibody responses. These data demonstrate that TNX-1800 infection was limited, asymptomatic, and cleared by the end of this study, and a single dose was able to generate immune responses.
TNX-1800 是一种处于临床前阶段的合成衍生减毒嵌合马痘病毒疫苗，经过基因工程改造后可表达 SARS-CoV-2 刺突（S）蛋白。本研究的目的是评估 TNX-1800 在叙利亚金黄地鼠和新西兰白兔中的安全性、耐受性和免疫原性。动物通过皮内接种接受三次疫苗接种。数据显示，单次经皮给予三种 TNX-1800 疫苗剂量水平在金黄地鼠和兔中均具有良好的耐受性。在所有剂量水平下，兔子对疫苗接种部位反应的辨别力均强于金黄地鼠。最后，在接种部位均未检测到 TNX-1800 基因组。接种后，所有动物均产生抗 SARS-CoV-2 刺突蛋白 IgG 特异性抗体反应。这些数据表明，TNX-1800 感染受到限制，为无症状感染，并在本研究结束时清除，单次剂量即可产生免疫反应。
