浙江省肾综合征出血热(HFRS)-Ⅰ型鼠脑纯化疫苗安全性、血清学、防病效果和免疫策略研究  

Study on the safety serological efficacy and epidemiolgical efficacy of vaccines against HFRS in Zhejiang province

作　　者：翁景清[1] 兰锦清[2] 赵芝雅[1] 方春福[3] 龚震宇[1] 林成渠[2] 吕跃民[3] 夏建华[1] 陈毓土[2] 余新顺 朱智勇[1] 徐江荣[2] 王炜[3] 王黎洪[2] 余樟友 季群伟[2] 张庆梅[2] 

机构地区：[1]浙江省疾病预防控制中心,杭州,310009 [2]龙游县疾病预防控制中心 [3]衢州市疾病预防控制中心

出　　处：《中国人兽共患病杂志》2002年第4期39-46,共8页Chinese Journal of Zoonoses

基　　金：国家"九五"医学科技攻关项目 (96-90 6-0 3 -13 )

摘　　要：目的　现场观察、考核兰州生物制品研究所生产的HFRS -Ⅰ型鼠脑纯化疫苗的安全性、血清免疫学与防病效果 ,并确定其免疫程序和免疫策略。方法　试验组和对照组按随机整群分组法进行分组 ;采用 0、7、2 8d及免后 1年加强 1针的免疫程序 ;分别采集免前、全程接种后 2周、加强前、加强后两周、加强后 1、2、3、4、5年的部分接种者全血和微量耳垂血 ,分别测定其中和抗体和IFA抗体 ,观察疫苗的血清免疫学效果和现场流行病学防病效果。结果　在 1995年 8月～ 2 0 0 1年 12月的 6年时间里从疫苗开始接种到加强后 5年 ,观察了HFRS -Ⅰ型鼠脑灭活纯化疫苗的安全性、血清免疫学效果和流行病学防病效果等。纵观结果 :证明该疫苗除了因疫苗中残留蔗糖导致较重较普遍的局部反应外 ,未发现其他严重的副反应 ,证明疫苗有较好安全性。从血清免疫效果看 ,86例全程接种后两周的免疫者血清 ,IFA抗体阳转率达 10 0 % ,中和抗体阳转率为4 4 4 4 % (8/ 18)。 1年后 ,IFA抗体和中和抗体阳性率分别下降到 2 8 5 7%和 14 80 %。但加强后 2周的血清IFA抗体和中和抗体阳性率分别反弹至 83 33%和 5 5 5 6 % ,其抗体几何平均滴度也随之回升 ,但不十分明显。此外 ,在加强后 2年IFA和中和抗体阳性率再次下降到较低水平 。Aim To observe the safety serological efficacy and epidemiological efficacy character of HFRS vaccine in the focus population with high incidence of HFRS in Zhejiang province from August 1995 to December 2001.Methods Immuno fiuorecent antibody assay was used in testing specific IgG antibody and Mcro CPE method was used in testing the titer of neutralizatin antibody.Results Two weeks after the injection,the seroconversion rate by Immunofluorecent antibody test(IgG) and neutraliation test was 100% and 44 44%(8/18).After 1 year,the rate of seroconversion of Immunofluorecent antibody by IFA method and the rate of seroconversion of neutralizatin antibody by the Mcro CPE method was decrease to 28 57% and 14 80% respectively.Two weeks after reforce,the rates of seroconversion of Immunofluorecent antibody and the neutralizing antibodyn were going up 83 33% and 55 56% respectively,and GMP was also going up.But they all droped again after one year,or 2 year,the rates of seroconversion of neutralizing antibody by the Mcro CPE method were decrease to 22 5%and 26 0% respectively.The reaction of vaccine was little.The vaccinated group had 1 patient and the control group had 26 patients.The protective rate of 6 years is 96 15%.We have found some antibodies.dependent on immunization enhancement phenomenon among the inoculated population,but still need observe.Conclusion HFRS vaccine has a better effect in epidemiology in the middle term and is safety.

关 键 词：浙江 肾综合征出血热 鼠脑纯化疫苗 血清免疫学效果 免疫策略 全程接种 防病效果 HFRS 

分 类 号：R512.8[医药卫生—内科学]