甲型肝炎减毒活疫苗（H2株）一针接种后免疫保护效果的15年观察  

Long-term immunogencity and effectiveness of live attenuated hepatitis A vaccine （H2-strain ）-a study on the result of 15 years＇ follow up

作　　者：庄昉成[1] 毛子安[1] 姜立民[1] 吴洁[1] 陈悦青[1] 姜器[2] 陈念良[1] 柴少爱[1] 毛江森[1] 

机构地区：[1]浙江省医学科学院病毒病研究所/浙江省医学生物工程疫苗研发重点实验室,杭州310013 [2]台州市椒江区疾病预防控制中心

出　　处：《中华流行病学杂志》2010年第12期1332-1335,共4页Chinese Journal of Epidemiology

基　　金：基金项目：“九五”自家科技攻关课题（030101）

摘　　要：目的 评估甲型肝炎（甲肝）减毒活疫苗（H2株）一针接种后的15年血清学和流行病学保护效果.方法 在浙江省台州市椒江区选择220名免前抗甲肝抗体阴性儿童（年龄1～3岁）作为血清免疫学追踪观察对象,分别于接种H2株疫苗后的2个月、12个月、6年、10年和15年观察抗甲肝抗体阳性率和几何平均滴度（GMT）.分析该观察区1～15岁儿童组疫苗接种率和甲肝发病率之间的关系及整个人群15年流行病学效果观察.血清学检测方法采用ELISA法（用WHO标准品校正）和ABBOTT（美国）AxSYM mEIA法.结果 在血清学追踪观察人群中疫苗接种后2个月和接种后15年,抗体阳转率分别为98.6%和81.3%,抗体阳转率下降缓慢 15年后抗-HAV-IgG的GMT为128 mIU/ml,显著高于WHO专家建议的20 mIU/ml保护水平.随着疫苗接种率的逐年提高,1～15岁年龄组儿童的甲肝发病率明显下降,二者之间有非常明显的相关性（Kendall-Rank 相关性检验,τ=-0.931,P＜0.01）.疫苗接种者连续15年累计观察236 413人年,未发生一例甲肝 而未接种者累计观察27 206人年,发生甲肝4例,疫苗保护率为100% 儿童大规模免疫接种为整个人群建立了良好免疫屏障,甲肝发病率下降幅度达96.7%.结论 甲肝减毒活疫苗（H2株）一针接种后的血清学和流行病学保护效果持久,可达15年.Objective To evaluate the long-term immunogencity and effectiveness of live attenuated hepatitis A （HA） vaccine （H2 strain） after one dose injection, through a 15 years＇ follow up observation. Methods A total of 220 children with negative anti-HAV antibody （aged 1-3 y）were involved and followed up in Jiaojiang district, Taizhou city, Zhejiang province. Indicators would include seroconversion and geometric meantiter（GMT） levels after inoculation the vaccine with single dose at 2 m, 12 m, 6 years, 10 years and 15 years. Epidemiological observation was carried out within the 15 years to evaluate the relationship between vaccine coverage, the incidence of HA and the overall effectiveness. In the studied population, serum was tested by ELISA（calibrated by WHO international reference） and ABBOTT Axsym HAVAB mEIA. Results Seroconversion rates were found to be 98.6% and 81.3% after 2 months and 15 years of inoculation and slowly decreased. GMT level was 128 mIU/ml after 15 years, significantly higher than the required protective level of 20 mIU/ml,recommended by WHO experts. Effectiveness through the 15-year follow up program showed a significant correlation between vaccine coverage and incidence of HA in 1-15 years aged group （Kendall-Rank test, t =-0.931, P〈0.01）. There was no HA case seen among the observed accumulated 236 413 person-year vaccines, compared to 4 HA cases discovered in the 27 206 personyear of the non-vaccinees. The overall protective rate reached 100%. Through a mass vaccination program on children, the whole population established an immune-defence to enable the incidence of HA decreased by 96.7%. Conclusion The long-term immunogencity and effectiveness of live attenuated hepatitis A vaccine （H2 strain） after one dose injection could last as long as 15 years.

关 键 词：甲型肝炎疫苗 免疫持久性 流行病学效果 

分 类 号：R186[医药卫生—流行病学]