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安全性评估:哈萨克斯坦 COVID-19 疫苗 QazCovid-in 的细菌内毒素定量含量比较分析及致热原性评价。

Safety Assessment: a Comparative Analysis of Quantitative Content of Bacterial Endotoxins and Evaluation of Pyrogenicity of the Kazakhstan Vaccine QazCovid-in against COVID-19.

机构信息

Laboratory for Control of Technologies and Biopreparations, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Republic of Kazakhstan.

Laboratory for Monitoring of Infectious Diseases, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Republic of Kazakhstan.

出版信息

Bull Exp Biol Med. 2024 Feb;176(4):452-456. doi: 10.1007/s10517-024-06045-8. Epub 2024 Mar 15.

DOI:10.1007/s10517-024-06045-8
PMID:38491256
Abstract

We measured the levels of bacterial endotoxins in the bulk vaccine product (BVP) and finished vaccine QazCovid-in and evaluated the effect of aluminum hydroxide (adjuvant) on the results of LAL test and pyrogenicity of samples in vivo (in rabbits receiving intravenous injection into the marginal ear vein). Administration of BVP with LPS resulted in a dose-dependent increase in body temperature in rabbits similar to that caused by LPS alone, which suggests that aluminum hydroxide in the vaccine did not affect the pyrogenic response in rabbits. Moreover, the LAL test showed that the aluminum hydroxide did not hinder LPS activity after serial dilution of samples.

摘要

我们测量了大体积疫苗产品(BVP)和成品疫苗 QazCovid-in 中的细菌内毒素水平,并评估了氢氧化铝(佐剂)对 LAL 试验结果和样品体内致热性(接受静脉内注射到耳缘静脉的兔子)的影响。在 LPS 存在的情况下给予 BVP 会导致兔子体温呈剂量依赖性增加,类似于单独给予 LPS 时的情况,这表明疫苗中的氢氧化铝不会影响兔子的发热反应。此外,LAL 试验表明,在对样品进行连续稀释后,氢氧化铝不会阻碍 LPS 的活性。

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Development of the Inactivated QazCovid-in Vaccine: Protective Efficacy of the Vaccine in Syrian Hamsters.灭活QazCovid-in疫苗的研发:该疫苗在叙利亚仓鼠中的保护效力
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