HBsAg阳性儿童和健康儿童对国产甲型肝炎灭活疫苗免疫原性和安全性的观察

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121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500U／剂和1000U／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500U／剂和1000U／剂甲型肝炎灭活疫苗后抗体阳转率均为100％。第二针免疫后30d抗体平均几何滴度500U／剂组分别为4684．9mIU和4535．6mIU；1000U／剂组分别为5399．8mIU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。

A comparative study on safety and immunogenicity of an inactivated hepatitis A vaccine in HBsAg carriers and healthy children

Objective To evaluate safety and immunogenicity of inactivated hepatitis A vaccine in HBsAg carriers and healthy children. Methods One hundred and twenty one healthy children and ten HBsAg carriers, aged 1 10 years,HAV susceptible were enrolled in the study.The inactivated hepatitis A vaccine was produced by Tangshan Biogenetic Company. The dosage of the vaccine was 1 000 U/Dosage and 500 U/Dosage. The vaccination schedule was six month apart for two injections. The serum anti HAV level was detected with EIA at one month after first injection and at one and six month after the booster injection, respectively. Results The anti HAV appeared in all the children. One month after the booster injection, the serum anti HAV level in children vaccinated 500 U/Dosage was 4 684.9 mIU and 4 535.6 mIU, respectively and in the children vaccinated 1 000 U/Dosage, 5 399.8 mIU and 7 347.1 mIU, respectively. The anti HAV level was not statistically different between the two groups of children. There was no adverse reaction after the vaccination. The anti HAV level was still high one year after first injection. Conclusion The data indicated that the safety and immunogenicity of the domestic inactivated hepatitis A vaccine were excellent in both groups of children.