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目的 观察HBsAg阳性儿童对国产甲型肝炎灭活疫苗的免疫原性和安全性。方法 随机选取 12 1名 1～ 10岁健康儿童和 10名同龄的HBsAg阳性儿童 ,抗 HAV均阴性 ,接种唐山怡安生物工程有限公司研制的甲型肝炎灭活疫苗。接种剂量为 5 0 0U 剂和 10 0 0U 剂两组 ,免疫程序为 0和 6个月 ,并在初免后 30d,第二针后 30和 180d用ELISA方法检测抗 HAV。结果 HBsAg阳性儿童和健康儿童接种 5 0 0U 剂和 10 0 0U 剂甲型肝炎灭活疫苗后抗体阳转率均为 10 0 %。第二针免疫后 30d抗体平均几何滴度 5 0 0U 剂组分别为 4 6 84 .9mIU和 4 5 35 .6mIU ;10 0 0U 剂组分别为 5 399 8mIU和 7347 1mIU。二者比较差异无显著性 ,免疫后亦未见异常反应 ,初免后 1年抗体水平仍然很高。结论 HBsAg阳性儿童接种国产甲型肝炎灭活疫苗具有良好的免疫应答 ,同时也是安全的。
Objective To observe the immunogenicity and safety of domestic HBsAg-inactivated vaccine against HBsAg-positive children. Methods A total of 12 1 healthy children aged from 1 to 10 and 10 HBsAg positive children of the same age were randomly selected. All of them were negative for anti-HAV and inoculated with Hepatitis A inactivated vaccine developed by Tangshan Aon Biological Engineering Co., Ltd. The vaccination doses were 500 U and 100 U doses. The immunization procedures were 0 and 6 months. Anti-HAV was detected by ELISA at 30 days and 30 and 180 days after the second immunization. Results The HBsAg positive children and healthy children were vaccinated with 500 U and 100 U doses of hepatitis A inactivated vaccine. The positive rate of antibody positive rate was 100%. After 30 days of the second immunization, the average geometric titers of antibodies were 4684.9mIU and 45.36mUU, respectively. The mean geometric titers of the antibodies were 5 399 8mIU and 7347 1mIU respectively. There was no significant difference between the two. No abnormal reaction was found after immunization. The level of antibody in 1 year after primary immunization was still high. Conclusion HBsAg-positive children inoculated with hepatitis A inactivated vaccine has a good immune response, but also safe.