孩尔来福甲型肝炎灭活疫苗不同免疫程序的评价  

Evaluation on Different Immunization Schedules of Hepatitis A Vaccine Healive~

作　　者：任银海 陈江婷[2] 吴文婷 公雪杰 张玉成 王建红[2] 薛伟华 任一丰 韩连军 康文学 李胜平 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》2003年第4期219-221,共3页Chinese Journal of Vaccines and Immunization

摘　　要：为评价孩尔来福 (Healive○R)甲型肝炎 (甲肝 )灭活疫苗不同免疫程序的免疫原性 ,在山区农村的 5个村 ,对 16 7名 5～ 11岁甲肝易感儿童 ,分 5组以 0、1,0、3,0、6 ,0、12个月程序接种Healive○R甲肝灭活疫苗 (2 5 0U/剂 ) ,对照组以0、6个月程序接种HavrixTM72 0EIU甲肝灭活疫苗。结果显示 :Healive○R甲肝灭活疫苗初次免疫 (初免 )后 2周、4周抗甲肝病毒抗体 (抗 HAV)阳转率分别为 97 0 %和 95 5 % ,几何平均滴度 (GMT)分别为 35 5mIU/ml和 2 5 1mIU/ml;初免后 3、6、12个月的抗 HAV阳转率均为 10 0 0 % ;GMT则分别为 4 17mIU/ml、391mIU/ml和 36 1mIU/ml。各程序组全程免疫后 1个月抗 HAV阳转率均为 10 0 0 % ;GMT则分别为 14 893mIU/ml(0、12个月 ) >5 96 3mIU/ml(0、6个月 ) >32 6 5mIU/ml(0、3个月 ) >1973mIU/ml(0、1个月 ) ,差异有非常显著的统计学意义。HavrixTM 甲肝灭活疫苗初免后 4周、6个月和全程免疫后 1个月 ,抗 HAV阳转率分别为 71 0 %、71 0 %和 10 0 0 % ,GMT为 15 8mIU/ml、15 2mIU/ml和 110 4mIU/ml。免疫 1剂Healive○R甲肝灭活疫苗GMT可达有效保护水平的 12倍以上。 0、1个月程序可用于特殊人群的加速免疫 ,0、3,0、6 ,0、12个月程序可根据不同人群的需求而灵活应用 ,以 0。With a view to evaluate the immunogenicity of different immunization schedules of the Healive D○R inactivated hepatitis A vaccine in five mountain area villages, 167 children aged 5～11 years old, seronegative for hepatitis A virus were randomly divided into five groups.Four groups administered 250U/dose vaccine according to 0、1,0、3,0、6 and 0、12 schedules respectively.The control group administered Havrix TM 720EIU inactivated hepatitis A vaccine. The results showed that the positive seroconversion rate were 97.0% and 95.5%,the geometric mean titers (GMTs) were 355mIU/ml and 251 mIU/ml,respectively by two and four weeks after the primary dose in trial groups.The seroconversion rate were all 100%, the GMTs were 417mIU/ml,391mIU/ml and 361mIU/ml by 3、6 and 12 months after the primary dose, respectively.Seroconversion rate were all 100% by the booster dose after one month in four groups: GMTs were 14,893mIU/ml(0、12),>5,963mIU/ml(0、6),>3,265mIU/ml(0、3),and 1,973mIU/ml(0、1),it had significant statistical difference.In control group,seroconversion rate were 71.0% and 71% 4 weeks and 6 months after the primary dose respectively and were 100% by one month after the booster dose; GMTs were 158mIU/ml、152mIU/ml and 1,104mIU/ml respective. The GMT protective level was over 12 time after receiving one dose of Healive D○R inactivated Hepatitis A vaccine. 0、1 immunization schedule can be used to accelerate the immunity, 0、3,0、6 and 0、12 schedules can be flexibaly applied according to requirements of diferent population, the 0、12 months is the best schedule..

关 键 词：孩尔来福 甲型肝炎 灭活疫苗 免疫程序 评价 免疫原性 

分 类 号：R512.61[医药卫生—内科学]