重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种质量评价  

Quality evaluation of recombinant adenovirus type-5-vectored COVID-19 variant vaccine(XBB.1.5 virus strain)

作　　者：吴小红[1] 杨立宏[1] 郑秀玉 赵丹华 黄艳秋 付瑞[1] 刘欣玉[1] 李玉华[1] 叶强[1] WU Xiao-hong;YANG Li-hong;ZHENG Xiu-yu;ZHAO Dan-hua;HUANG Yan-qiu;FU Rui;LIU Xin-yu;LI Yu-hua;YE Qiang(National Institutes for Food and Drug Control,Beijing 102629,China;CanSino Biologics,Tianjin 300480,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]康希诺生物股份公司,天津300480

出　　处：《药物分析杂志》2023年第12期2165-2170,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种进行质量评价。方法:利用PCR和琼脂糖凝胶电泳对毒种进行腺病毒载体鉴别和目的基因鉴别,以鉴别其载体是否为腺病毒载体、插入序列是否正确;对毒种进行病毒感染滴度(IFU)检测,以评估其病毒感染力;对毒种进行无菌检查、支原体检查、外源病毒因子检查、腺相关病毒(AAV)检测,以检测是否有外源性污染。结果:腺病毒载体和插入片段均正确,毒种具有很高的感染力,且无细菌、真菌、支原体、外源病毒因子、腺相关病毒(AAV)污染。结论:重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种质量符合已上市同类产品质量标准,鉴别、活性和安全性指标检验方法对于疫苗生产具有指导意义。Objective:To evaluate the quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed(XBB.1.5 virus strain).Methods:Conducted viral vector identity and target gene identity by PCR and agarose gel electrophoresis to determine whether it was an adenovirus type vector and whether the insertion fragment was correct;conducted infectious viral titer(IFU)test to evaluate the infectivity of the virus;conducted sterility test,mycoplasma test,extraneous virus agents test,and adeno-associated virus(AAV)test on the virus seed to detect whether there was exogenous contamination.Results:The results showed that the vector and inserted fragment of the virus seed were correct,and the virus seed was with high infectivity and no bacteria,fungi,mycoplasma,extraneous virus agents and adeno-associated virus(AAV).Conclusion:The quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed(XBB.1.5 virus strain)met the specification of products approved.The viral vector identity and target gene identity,infectious viral titer test and methods about vaccine safety had guiding significance for vaccine production.

关 键 词：新型冠状病毒 腺病毒载体 疫苗 XBB 毒种 质量评价 

分 类 号：R917[医药卫生—药物分析学]