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[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。
[Objective] To understand the safety and immunogenicity of immunization of rhesus monkeys with live-attenuated attenuated freeze-dried hepatitis A vaccine produced in cell factories and spinner flasks. [Method] Rhesus monkeys were vaccinated by intravenous injection, and the clinical symptoms, signs, biochemistry, immunological reaction and pathological changes of liver tissue were observed. [Results] No abnormal changes of clinical symptoms and signs were found in the live-attenuated attenuated vaccine of freeze-dried hepatitis A in cell factories and spinner flasks. ALT was normal, anti-HAV was continuously positive during the observation period, and liver tissue was free of viral hepatitis Pathological changes. [Conclusion] The freeze-dried hepatitis A attenuated live vaccine produced by cell factory and spinner bottle technology has the same immunological effect on rhesus monkeys, and has good protective effect.