健康儿童接种国产甲型肝炎灭活疫苗的免疫效果研究  

Study on the Immune Effect of a Domestic Inactivated Hepatitis A Vaccine Among Healthy Children

作　　者：周义红[1] 吴建方[1] 王旭[2] 刘研[2] 陈江婷[2] 

机构地区：[1]江苏省常州市武进区疾病预防控制中心,江苏常州213164 [2]北京科兴生物制品有限公司

出　　处：《实用预防医学》2013年第1期28-31,共4页Practical Preventive Medicine

摘　　要：目的评价国产甲型肝炎（甲肝）火活疫苗（hepatitis A vaccine，inactivated；HepA-I）的免疫原性技免疫持久性。方法采用随机双盲设对照的临床研究设计，试验疫苗使用国产HepA-I，选取进口HepA-I做对照，试验疫曲与对照疫苗的比例为3：1，其中国产HepA-I的剂量为每支250单位（Unit，U）／0．5ml（ml），进口HepA-I的剂量为恕支720ELISA单位（enzyme linkedin mlunosorbent assay unit，Elu）／0．5ml。在常州市武进区筛选出213名2～8岁健康儿童为受试者，完成0、6个月免疫程序接种后连续观察5年，每年采血检测抗甲肝病毒抗体（antibody to hepatitis A virus，Anti HAV）。结果完成全程免疫后1个月以及第1～4年，试验组和对照组阳性率均为100％，第5年两组分别为99．1％和97．3％；完成伞程免疫后1个月，试验组和对照组Anti—HAV的几何平均滴度（geometric mcan concentration，GMC）为4079．6毫国际单化（mlU）／ml和l394．6mlU／ml，至第5年Anti-HAVGMC分别为308．2mlU／ml和195．1mlU／ml，差异均有统计学意义（分别t=6．577，P〈0．001；t=2．748，P=0．007）。结论国产HepA—1在全程免疫接种后的免疫原性及免疫持久性良好。Objective To evaluate the immunogenicity and immune persistence of a Chinese domestic hepatitis A vaccine, inactivated （HepA- 1） among children. Methods A randomized double blind clinical trial was conducted in Wujin District of Changzhou city in 213 healthy children aged from 2 to 8 years and with negative antibodies to hepatitis A virus （Anti - HAV）. After they had completed two doses of full immunization of HepA- I, they were observed for 5 years. The dosage of the domestic trail HepA- I was 250 unit （U） /0.5ml and the dosage of the imported control HepA- I was 720 enzyme linked immunosorbent assay unit （Elu）/0.5ml. The ratio of the subjects receiving the trial vaccine to those receiving the control vaccine was 3：1. Anti - HAV titers were determined 1, 6 and 7 months and 1 to 5 years after the full immunization. Results One month and one to four years after the full vaccination, the seroconversion rates of the trial group and the control group were both 100 %. In the 5th year, the seroconversion rates were 99.1% and 97.3 %, respectively. The geometric mean concentrations （GMCs） of the trial group and the control group in the 1st month after the full vaccination were 4,079.6 mlU/ml and 1,394.6 mIU/ml, respec- tively, and dropped to 308.2 mlU/ml and 195.1 mlU/ml in the 5th year, both indicating statistical differences （ t = 6. 577, P〈 0. 001 ; t = 2. 748, P= 0. 007, respectively）. Conclusions The domestic inactivated hepatitis A vaccine has a sound irnmu- nogenicity and immune persistence after two doses of full immunization among children.

关 键 词：甲型肝炎灭活疫苗 免疫原性 免疫持久性 儿童 

分 类 号：R186[医药卫生—流行病学]