首支哈萨克斯坦国产新冠病毒灭活疫苗的安全性和免疫原性。
Safety and immunogenicity of the first Kazakh inactivated vaccine for COVID-19.
机构信息
Research Institute for Biological Safety Problems (RIBSP), Guardeyskiy, Kazakhstan.
出版信息
Hum Vaccin Immunother. 2022 Nov 30;18(5):2087412. doi: 10.1080/21645515.2022.2087412. Epub 2022 Aug 12.
This article describes the results of a preclinical safety and immunogenicity study of QazCovid-in®, the first COVID-19 vaccine developed in Kazakhstan, on BALB/c mice, rats, ferrets, Syrian hamsters and rhesus macaques (). The study's safety data suggests that this immunobiological preparation can be technically considered a Class 5 nontoxic vaccine. The series of injections that were made did not produce any adverse effect or any change in the general condition of the model animals' health, while macroscopy and histology studies identified no changes in the internal organs of the BALB/c mice and rats. This study has demonstrated that a double immunization enhances the growth of antibody titers as assessed by the microneutralization assay (MNA) and the enzyme-linked immunosorbent assay (ELISA) in a pre-clinical immunogenicity test on animal models. The best GMT results were assessed in MNA and ELISA 7 days after re-vaccination; however, we noted that GMT antibody results in ELISA were lower than in MNA. A comparative GMT assessment after the first immunization and the re-immunization identified significant differences between model animal groups and a growth of GMT antibodies in all of them; also, differences between the gender groups were statistically significant. Moreover, the most marked MNA immune response to the QazCovid-in® vaccine was seen in the Syrian hamsters, while their SARS-CoV-2-specific antibody activity as assessed with ELISA was the lowest.
这篇文章描述了在 BALB/c 小鼠、大鼠、雪貂、叙利亚仓鼠和恒河猴()中进行的 QazCovid-in ®,即哈萨克斯坦开发的首款 COVID-19 疫苗的临床前安全性和免疫原性研究结果。该研究的安全性数据表明,这种免疫生物制剂在技术上可以被认为是 5 级无毒疫苗。一系列注射未产生任何不良反应,也未改变模型动物健康的一般状况,而宏观和组织学研究未发现 BALB/c 小鼠和大鼠内部器官有任何变化。这项研究表明,在动物模型的临床前免疫原性试验中,两次免疫增强了抗体滴度的增长,这可以通过微量中和试验(MNA)和酶联免疫吸附试验(ELISA)来评估。在再次接种后 7 天,通过 MNA 和 ELISA 评估得出了最佳的 GMT 结果;然而,我们注意到 ELISA 中的 GMT 抗体结果低于 MNA。首次免疫和再次免疫后的 GMT 评估确定了模型动物组之间存在显著差异,并且所有组的 GMT 抗体均有所增长;此外,性别组之间的差异具有统计学意义。此外,QazCovid-in ® 疫苗在叙利亚仓鼠中引起的 MNA 免疫反应最为明显,而它们的 SARS-CoV-2 特异性抗体活性通过 ELISA 评估却是最低的。