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于1993~1997年间采用本院批量生产的22批甲肝减毒活疫苗对234名ALT值正常、抗HAV阴性的7~8岁儿童进行了人体接种.对其中9批进行了45只猕猴的接种。经观察,全部疫苗对人体均未产生局部和全身不良反应.抗体阳转率为88%~100%,平均96%;猴血清ALT测定,肝脏穿刺病理学检查均未见异常,抗体阳转率亦达96%.这一结果表明疫苗质量稳定、安全且免疫效果良好。
From 1993 to 1997, 22 batches of attenuated live attenuated hepatitis A vaccine were used to inoculate 234 children with normal ALT and anti-HAV negative 7-8 years old. Of the 9 batches, 45 macaques were vaccinated. After the observation, all vaccines have no local and systemic adverse reactions to human body. The antibody positive rate was 88% -100%, with an average of 96%. No abnormalities were found in the serum ALT and liver biopsy, and the positive rate of antibody positive was 96%. This result shows that the quality of the vaccine is stable, safe and well-immunized.