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细胞工厂制备冻干甲型肝炎减毒活疫苗猴体安全性和免疫原性研究
引用本文:周妍,仲宇航,王云霞,张立志,战永生,苏宇,冯玉梅,刘景晔.细胞工厂制备冻干甲型肝炎减毒活疫苗猴体安全性和免疫原性研究[J].预防医学文献信息,2012(7):526-527.
作者姓名:周妍  仲宇航  王云霞  张立志  战永生  苏宇  冯玉梅  刘景晔
作者单位:长春长生生物科技股份有限公司,吉林长春130103
摘    要:目的]了解细胞工厂和转瓶工艺生产的冻干甲型肝炎减毒活疫苗免疫恒河猴后的安全性和免疫原性。方法]用静脉注射的方式为恒河猴接种疫苗,观察恒河猴的临床症状、体征、生化、免疫学反应以及肝组织的病理变化。结果]细胞工厂和转瓶工艺生产的冻干甲型肝炎减毒活疫苗均未见临床症状和体征的异常改变,ALT正常,抗-HAV在观察期内持续阳性,肝组织无病毒性肝炎的病理性改变。结论]细胞工厂和转瓶工艺生产的冻干甲型肝炎减毒活疫苗对恒河猴的免疫效果相同,具有良好的保护作用。

关 键 词:冻干甲型肝炎减毒活疫苗  细胞工厂  安全性  免疫原性

Safety and Immunogenicity Testing of Monkey in the Preparation of Hepatitis A (Live) Vaccine, Freeze-dried by Cell Factory
Institution:ZHOU Yan ,ZHONG Yu-hang ,WANG Yun-xia ,etal. (Changchun Changsheng Life Sciences Ltd ,Changchun, 130103 , J ilin , China )
Abstract:Objective]To compare safety and immunogenicity of rhesus after vaccination of Hepatitis A (Live) Vaccine,freeze-dried manufactured by cell factories and roller bottles process, i-Methods]Vaccine should be injected by intrave- nous injection,observe the clinical symptoms, signs,biochemical, immunological reactions and pathological changes of liver tissues of rhesus. Results]No abnormal clinical signs were observed from both groups, ALT, anti-HAV antibody were persistently positive during the observation period,no viral hepatitis pathological changes on liver tissues. Conclusion]The immune effect of manufacturing process of cell factories and roller bottles of Hepatitis A (Live) Vaccine, freeze-dried are the same,they all have good protective effect from Hepatitis A.
Keywords:Hepatitis A (Live) Vaccine  Freeze-dried  Cell factory  Safety  Immunogenicity
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