中国媒介生物学及控制杂志

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肾综合征出血热疫苗效果免疫(感染)增强和免疫策略研究中期评估报告

“九五”国家医学科技攻关专题(96-906-03-13)协作组   

  • 出版日期:1998-10-20 发布日期:1998-10-20

MiddleTerm Report on Evaluation of Efficacy of HFRS Vaccinesand Study on Antibody Dependent Immunization Enhancementand Immunology Strategy

Cooperative Group on the Ninth-Five Years National Medical Scientific study 96-906-03-13   

  • Online:1998-10-20 Published:1998-10-20

摘要: 目的:继续观察沙鼠肾细胞Ⅰ型灭活疫苗、乳鼠脑纯化Ⅰ型灭活疫苗和地鼠肾细胞Ⅱ型灭活疫苗的安全性、血清学和防病效果。方法:采取现场与实验室结合的方法。现场试验人群采用整群随机分组,分为疫苗接种组和对照组。实验室血清抗体检测采用间接免疫荧光法(IFAT)、微量细胞病变中和试验(MCPENT)、酶联免疫吸附试验(ELISA)和血凝抑制试验(HI)。结果:3种疫苗安全性较好,临床上未出现接种人群免疫(感染)增强反应。从3种疫苗全程基础免疫后14天、1年、2年和3年时中和抗体和荧光抗体的抽样检出情况看,在基础免疫后1年时中和抗体阳性率平均降到13.96%,此时加强免疫1针14天时中和抗体阳性率平均可升高到73.49%,基础免疫后3年时中和抗体阳性率平均降到27.81%。荧光抗体阳性率增减的变动规律与中和抗体类似。结论:3种疫苗防病效果良好,在基础免疫后3年内,每年平均保护率均高于90%。根据研究结果,进一步提出了免疫策略建议。

关键词: 肾综合征出血热, 灭活疫苗, 免疫增强, 防病效果, 免疫策略

Abstract: Objective:To go on observing the safety,immunology efficacy and protective efficacy of three different kinds of inactivated vaccines against HFRS:Type Ⅰ vaccines prepared from tissue culture of Mongolian gerbils kidney,type Ⅰ vaccines purified from mouse brains and type Ⅱ vaccines prepared from tissue culture of hamster kidney.Methods:The study combined field work and laboratory work.People in the study areas were randomized to vaccine group or control group.Antibody titers were tested by immunofluorescent antibody assay (IFA),Microcytopathic effect neutralization test (MCPENT),enzymelinked immunosorbent assay (ELISA) and hemagglutination inhibition test (HI).Results:These three kinds of vaccines were all safe.Antibody dependent immunization enhancement phenomenon was not observed among the inoculated population.Neutralizing antibody and immunofluorescent antibody were tested 14 days and 1 to 3 years after three doses of injection.The neutralizing antibody positive rate had declined to about 13.96% 1year after primary vaccination and increased to 73.49% 14 days after the booster dose (given 1 year after primary vaccination).At the third year after primary vaccination the neutralizingantibody positive rate declined to 27.81%.Similar changes of the immunofluorescent antibody positive rate were also observed.These three kinds of vaccines had remarkable preventive effect.The annual average protection rates were higher than 90% in all the 3 years after the primary vaccination.From these results,further suggestions on the immunology strategy were offered.