孩尔来福甲型肝炎灭活疫苗接种乙型肝炎病毒表面抗原阳性儿童的研究  

Vaccination of Healive Inactivated Hepatitis A Vaccine to HBsAg Positive Children

作　　者：任银海 陈江婷[2] 任一丰 公雪杰 吴文婷[2] 王建红[2] 康文学 韩连军 李胜平 薛伟华 张玉成 刘崇柏[3] 

机构地区：[1]平山县卫生防疫站,河北平山050400 [2]北京科兴生物制品有限公司,北京100085 [3]中国疾病预防控制中心,北京100050

出　　处：《中国计划免疫》2004年第1期44-46,共3页Chinese Journal of Vaccines and Immunization

摘　　要：为进一步观察孩尔来福 (Healive)甲型肝炎 (甲肝 )灭活疫苗在乙型肝炎病毒表面抗原 (HBsAg)阳性儿童中接种的安全性和免疫原性 ,于 2 0 0 1年在平山县农村 ,将 4 2例HBsAg阳性儿童随机分为 4组 ,分别按照 0、1,0、3,0、6 ,0、12个月程序接种Healive甲肝灭活疫苗 ,观察初免和全程免疫后的局部和全身反应 ,检测初免及全程免疫后 1个月血清抗甲肝病毒抗体 (抗 HAV)阳转率和滴度。结果显示 :初免和全程免疫后 72h内均未见局部和全身反应 ,亦无丙氨酸氨基转移酶 (ALT)异常 ;4个组初免后 1个月 ,抗 HAV阳转率均达 10 0 0 % ,抗体几何平均滴度 (GMT)为173mIU/ml～ 318mIU/ml,其差异无显著的统计学意义 (t=1 2 0 4 ,P >0 0 5 )。全程免疫后 1个月 ,0、12 ,0、6 ,0、3,0、1个月免疫程序组GMT分别为 192 99mIU/ml、4 30 1mIU/ml、2 74 9mIU/ml、172 5mIU/ml,与同龄健康易感儿童按相同免疫程序的免疫效果规律一致。全程免疫后 1个月 ,HBsAg阳性儿童和健康儿童抗 HAVGMT的差异无显著的统计学意义 (P >0 0 5 )。表明HBsAg对Healive甲肝灭活疫苗的免疫应答无干扰 ;HBsAg阳性儿童接种Healive甲肝灭活疫苗是安全和有效的。To evaluate the safety and immunogenicity of the Healive inactivated hepatitis A vaccine in HBsAg positive children,42 anti-HAV antibody negative,ALT normal,and HBsAg positive children of 4-10 years old were selected from the mountain village of Hebei Province and were divided into four groups that administered the 250U/dose vaccine according to 0?1,0?3,0?6 and 0?12 month schedules respectively.The local and systemic reactions and serum antibody to the vaccine were observed after the first dose and the booster dose.The results showed that no adverse reaction was observed within 72h after the first and the booster doses.ALT was not abnormal.The positive seroconversion rates of HAV antibody were all 100% in four groups after the first dose,the GMTs was 173 mIU/ml～318mIU/ml,which had no statistical significance (t=1.204,P>0.05) .GMTs were 19229mIU/ml(0?12 month),4*!301mIU/ml(0?6month),2*!749mIU/ml(0?3month) and 1*!725 mIU/ml(0?1month) after the booster dose respectively.The immunoreaction between HBsAg positive children and the healthy children of the same age was not different one month after two-dose vaccination. GMT also had no statistical difference.HBsAg didn't interfere with the immune response of Healive inactivated hepatitis A vaccine.This vaccine was proved to be safe and effective to HBsAg positive children.

关 键 词：孩尔来福 甲型肝炎灭活疫苗 疫苗接种 乙型肝炎病毒 病毒表面抗原 阳性 免疫原性 

分 类 号：R512.61[医药卫生—内科学] R186[医药卫生—临床医学]