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目的观察纯化甲型肝炎灭活疫苗(Vero细胞)接种普通狨猴的安全性和免疫原性。方法将800EU/0.5ml和1600EU/ml两个剂量的纯化甲肝灭活疫苗(JS-4株)与进口疫苗(50U/ml)分别接种普通狨猴各2只,进行安全性和免疫原性检测,并进行强毒(JS-12株)攻击保护试验及毒力试验。结果接种疫苗后72h,各组狨猴均未发生局部及全身反应;有特异性抗-HAV产生;肝脏血清酶活性均有一过性升高,未见肝脏病理改变;并均能抵抗甲肝病毒强毒株(JS-12)的攻击;JS-4毒株采用106.67CCID50/ml剂量接种狨猴后未见毒力反应,但产生了73000mIU/ml的高水平抗体;而JS-12毒株接种狨猴后,狨猴出现肝脏血清酶活性升高和肝组织病理学改变。结论纯化甲型肝炎灭活疫苗具有良好的安全性和免疫原性。
Objective To observe the safety and immunogenicity of purified monkeys administered with Viral Inactivated Vaccine (Vero cells). Methods Two purified marketed inactivated hepatitis A (JS-4) vaccines and two imported marketed vaccines (50U / ml) at doses of 800EU / 0.5ml and 1600EU / ml were respectively inoculated into two normal marmosets for safety and immunogenicity detection , And the virulent (JS-12 strain) attack protection test and virulence test. Results 72h after vaccination, no local and systemic reactions occurred in all of the marmosets. Specific anti-HAV production and liver serum enzyme activity were transiently elevated with no pathological changes of liver. All of them were resistant to hepatitis A virus (JS-12). JS-4 strain showed no virulence after inoculation with 106.67 CCID50 / ml, but produced high level antibody of 73000 mIU / ml. JS-12 strain was inoculated with After the monkey, marmosets appear liver serum enzyme activity and liver histopathological changes. Conclusion The purified hepatitis A inactivated vaccine has good safety and immunogenicity.