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针对COVID-19的冠状病毒蛋白基亚单元疫苗的临床前安全性和免疫性研究

Kamshat Shorayeva¹, Aziz Nakhanov¹, Ainur Nurpeisova¹

¹Research Institute for Biological Safety Problems, The Ministry of Health of the Republic of Kazakhstan, Gvardeiskiy 080409, Kazakhstan.

|December 23, 2023

概括

该QazCoVac-PCOVID-19亚单元疫苗证明了安全性,并在动物模型中诱导了显著的抗体反应. 根据这些有希望的临床前发现,建议对SARS-CoV-2预防进行进一步的临床试验.

科学领域:

疫苗学疫苗学疫苗学
免疫学免疫学免疫学
传染性疾病传染性疾病

背景情况:

开发安全有效的疫苗对于控制COVID-19流行病至关重要.
存在各种疫苗平台,但全球对快速预防的需求需要进一步开发.
临床前安全性和免疫性证据是疫苗部署的强制性先决条件.

研究的目的:

评估哈萨克斯坦开发的COVID-19亚单位疫苗QazCoVac-P的安全性,毒性和免疫性.
确定适当的免疫剂量并评估疫苗在预防SARS-CoV-2方面的潜力.

主要方法:

使用子模型和Limulus Amebocyte Lysate (LAL) 试验评估了疫苗的可燃性.
在BALB/c小鼠和大鼠中评估了急性和次慢性毒性.
在双重免疫接种后,通过ELISA测量了小鼠,雪,叙利亚仓鼠和 rhesus macaques 的抗体标位.

主要成果:

在动物毒性研究中,QazCoVac-P疫苗没有显示出与毒性相关的临床显著变化.
疫苗引起了强大的免疫反应,测试动物的最大平均几何抗体标位约为8 log2.
临床前的安全性和免疫性数据支持了疫苗的潜力.

结论:

在临床前的动物模型中,QazCoVac-P表现出了有利的安全性和显著的免疫性.
研究结果证明,建议QazCoVac-P用于进一步的临床试验.
QazCoVac-P显示出作为潜在的COVID-19预防子单位疫苗候选人的承诺.

关键词:

在 COVID-19 疫情中,抗原是一种抗原.免疫剂量的免疫剂量.免疫性免疫性免疫性免疫性在安全方面,安全是安全的.一个子单位的疫苗.毒性的毒性毒性的毒性

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Conjugated Proteins

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