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

“九五”国家医学科技攻关96-906-03-13专题协作组   

  • 出版日期:1997-10-20 发布日期:1997-10-20

Evaluation on the Efficacy of Vaccines against HFRS and Study on their Antibody Dependent Immunization Enhancement and Immunological Strategy

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

  1. Actual writer:Chen hua-xin
  • Online:1997-10-20 Published:1997-10-20

摘要: 目的:观察我国1993~1994年试生产的肾综合征出血热(HFRS)沙鼠肾细胞Ⅰ型灭活疫苗(上海生研所和杭州天元公司生产)、乳鼠脑纯化Ⅰ型灭活疫苗(兰州生研所生产)、地鼠肾细胞Ⅱ型灭活疫苗(长春生研所生产)的安全性,考核血清学、近期和中期流行病学效果。方法:采用IFAT法检测特异性IgG抗体,用MCPENT法检测中和抗体滴度。结果:3种疫苗安全性皆较好,上海沙鼠苗、天元沙鼠苗、鼠脑苗和地鼠苗中强反应率分别为0.56%、0.03%、3.26%、1.57%。3种疫苗3针全程免疫后14天、加强前、加强后14天和1年,中和抗体阳转率平均为:地鼠苗78.36%、12.33%、80.56%和54.46%,上海沙鼠苗57.81%、10.79%、70.71%和35.58%,天元沙鼠苗70.00%、50.00%、91.18%和未到期,鼠脑苗51.09%、10.48%、61.90%和45.00%;荧光抗体阳转率地鼠苗为65.73%、33.90%、85.00%和49.44%,上海沙鼠苗93.69%、17.76%、89.04%和51.61%,天元沙鼠苗83.33%、12.90%、64.52%和未到期,鼠脑苗84.27%、12.50%、81.25%和0%。3种疫苗近期(基础免疫后1年)和中期(基础免疫后2年)流行病学防病效果均较好,其平均保护率:地鼠苗分别为97.81%、88.73%,上海沙鼠苗94.08%、92.17%,天元沙鼠苗100.00%、100.00%,鼠脑苗88.45%、100.00%。试区内疫苗接种者再感染发病与未接种者感染发病的病情轻重无明显差别;接种者在流行高峰期后抗体阳转或增高者(视为再感染)均无症状。目前我们尚未发现接种人群中有免疫(感染)增强问题。结论:3种疫苗近期(基础免疫后1年)和中期(基础免疫后2年)流行病学防病效果均较好,并对免疫策略提出建议。

关键词: 肾综合征出血热, 灭活疫苗, 预防效果, 免疫增强, 免疫策略

Abstract: Objective: The purpose of this report was to observe the safety, serological efficacy, shortterm and long-term epidemiological efficacy character of three different kinds of inactivated vaccines against HFRS (Type l vaccines purified from tissue culture of Mongoian gerbils kindney, supplied by Institute of Biological Preducts, Shanghai and Tianyuan Cwnpany; type I vaccines purified from mouse brains supplied by Institute of BioIogical Products, Lanzhou; type IIvaccines prepared from tissue culture of hamster kidney, supplied by Institute of Bidogical Products, Changchun), which pr0cluced from 1993to 1994 in China.Methods used in antibody test: Immunofluorescent antithey assay was used in testing specific IgG antithey and McrcaCPE methed was used in testing the titer of neutralizing antidriy.Results:The three kinds of vaccines were all safe.The moderate and severe side effects of them were 0.56%,0.03%, 3.26% and 1.57% respectively.14 dayS after three doses of injection, before reinforced, 14 days and 1 year after reinforced.The rates of the rates of serocoversion of neutralizing antibody by the Mcro-CPE methed were 78.36%, l2.33%, 8O.56% and 54.46% for hamster kidney vaccines57.81%, 10.79%, 70.71% and 35.58% for Shanghai Mongoian gerbils kidncy vaccines;7O.00%, 50.00%, 91.18% and unknown (not yet completed) for Tianpon MOngian gerbils kidney vaccines; 51.O9%, 10.48%, 61.90% and 45.00% for mouse brains vaccines.The rates of seroconversion of immunonuorescent antibody by IFA method were 65.73%, 33.90%, 85.00% and 49.44% for hamster kidney vaccines; 93.69%, 17.76%, 89.04% and 51.61% for Shanghai Wgoian gErbils kidney vaccines;83.33%, 12.90%, 64.52% and unknown (not yet completed) for TianyUall Mongoian gerbils kidney vaccines; 84.27% , 12.50%, 81.25% and 0% for mouse brains vaccines.According to the short-term (1 year after primary immunization) and middle-term (2 years after primary immunizatbo)observation, these three kinds of vaccines were effective, and their protection rates in population were 97.81%, 88.73% for hamster kidney vaccines; 94.08%, 92.17% for Shanghai Mongoian gerbils kidney vaccines; 100.00%, 100.00% for Tianyuan Mongolian gerbils kidney vaccines; 88.45%, 100.00%for mouse brain vaccines.There was no significant difference in clinical manifestation between the inoculated and un-inoculated people after another infection.After the epidemic peak, the inoculated individuals didn't show any clinical symptom while had seroconversion or increase of antithey titer which could be defined as second infection.Till now, we haven't find any antibody dependent immunhatbo enhancernent phenomenon among the inoculated Population.Conclusion: According to the short-term and middle-term (1 or 2 years after primary immunization) observation, these three kinds of vaccines were all ePidendologically effective.We also offered some suggestions on the immunofogcal strategy.