四价流感病毒裂解疫苗安全性和免疫原性研究  

Safety and immunogenicity of quadrivalent influenza split-virion vaccine

作　　者：谭小东 王丽 许娜娜 TAN Xiaodong;WANG Li;XU Nana(Anhui Zhifei Longcom Biopharmaceutical Co,Ltd , Hefei 2300881 Anhui,China)

机构地区：[1]安徽智飞龙科马生物制药有限公司

出　　处：《安徽预防医学杂志》2019年第3期203-206,共4页Anhui Journal of Preventive Medicine

摘　　要：目的探讨四价流感病毒裂解疫苗的安全性和免疫原性。方法使用世界卫生组织推荐的北半球疫苗株制备四价流感病毒裂解疫苗,检定合格后,用于开展全面的动物毒理试验和免疫原性研究。结果ICR小鼠毒理试验结果显示,疫苗最大耐受量MTD大于1200μg/kg;家兔免疫原性试验结果显示,血凝抑制抗体滴度大于1:40,阳转率达到100%,血清中的中和抗体能够保护鸡胚不受流感病毒感染。结论动物试验表明,该疫苗显示出良好的安全性和免疫原性。Objective To evaluate the safety and immunogenicity of quadrivalent influenza split-viron vaccine.Methods The quadrivalent influenza split-viron vaccine was prepared by using the northern hemisphere vaccine strain recommended by WHO.After being qualified, it can be used for comprehensive animal toxicological test and immunogenicity study.Results The toxicological test of ICR mice showed that the maximum tolerated dose(MTD) of the vaccine was more than 1200 ug/kg, and the immunogenicity test of rabbits showed that the titer of hemagglutination inhibitory antibody was more than 1 :40 and the positive conversion rate was 100%.The neutralizing antibody in serum could protect chicken embryos from influenza virus infection.Conclusion Animal tests showed that the vaccine showed good safety and immunogenicity.

关 键 词：四价流感病毒裂解疫苗 安全性 免疫原性 中和抗体 血凝抑制抗体 

分 类 号：R186[医药卫生—流行病学]