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

被引:0
作者
Jekebekov, K. K. [1 ]
Nurpeisova, A. S. [1 ]
Abay, Zh. S. [1 ]
Shorayeva, K. A. [1 ]
Absatova, Zh. S. [1 ]
Abitayev, R. T. [1 ]
Kalimolda, E. Zh. [1 ]
Moldagulova, S. U. [1 ]
Assanzhanova, N. N. [2 ]
Omurtay, A. D. [1 ]
Shayakhmetov, Ye. A. [1 ]
Sadikaliyeva, S. O. [1 ]
Barakbayev, K. B. [3 ]
Kassenov, M. M. [1 ]
Zakarya, K. D. [4 ]
Abduraimov, Ye. O. [4 ]
机构
[1] Minist Hlth Republ Kazakhstan, Res Inst Biol Safety Problems, Lab Control Technol & Biopreparat, Guardeyskiy, Kazakhstan
[2] Minist Hlth Republ Kazakhstan, Res Inst Biol Safety Problems, Lab Monitoring Infect Dis, Guardeyskiy, Kazakhstan
[3] Minist Hlth Republ Kazakhstan, Res Inst Biol Safety Problems, Lab Technol Finished Forms Biopreparat, Guardeyskiy, Kazakhstan
[4] Minist Hlth Republ Kazakhstan, Management Dept, Res Inst Biol Safety Problems, Guardeyskiy, Kazakhstan
关键词
coronavirus infection; vaccine; pyrogenicity; bacterial endotoxins; LAL test; ALUMINUM;
D O I
10.1007/s10517-024-06045-8
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
We measured the levels of bacterial endotoxins in the bulk vaccine product (BVP) and finished vaccine QazCovid-in (R) 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.
引用
收藏
页码:452 / 456
页数:5
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