肾综合征出血热疫苗免疫效果和免疫策略研究

目的 现场验证HFRS-I型鼠脑纯化疫苗的安全性、血清免疫学与防病效果。方法 按随机整群分接种组，全程接种9012人和对照组16203人。采用0、7、28d及免后1年加强一针的免疫程序；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年的部分接种全血和微量耳血，分别测定中和抗体和IFA抗体。结果经1995年8月-2000年12月的5年间现场验证表明：HFRS-1型鼠脑灭活纯化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，证明该疫苗有较好安全性，从血清免疫效果看。86例全程接种后两周的免疫血清，IFA抗体阳转率达100%，中和抗体阳转率为44.44%，1年后，IFA抗体和中和抗体阳性率分别下降到28.57%和14.80%。但加强后两周的血清IFA抗体和中和抗体阳性率分别反弹至83.33%和55.56%，其抗体几何平均滴度（GMT）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，分别为22.5%和26.0%，到加强后4年，其中和抗体几乎全部转阴，但IFA抗体仍保持较高的阳性率。在接种组人群中除1例因接种2针，1例虽接种3针，未按规定程序接种而发病外，至今未发生其他病例，而对照组人群中已发病26例，其5例平均保护率达94.01%。结论 现场观察结果证明该疫苗具有安全性好，血清免疫学效果维持时间较长，现场防病效果可靠，对疫苗接种人群至少可保护5年以上，该疫苗值得在广大疫区推广应用。

Study on the Effects and Stragety of the HFRS Vaccine

Objective To observe the safety, serum antibody level and epidemiological effectiveness of the HFRS -1 .Methods Mass immunizadon was done in Longyou county Zhejiang province from August 1995 to December 2000.9012 people vaccinated at 1st, 7th, 28th day and reinforced one years later, and 16203 people not vaccinated as the control group.Results Special IgG was determined with indirect immunofluorescent assay (IFA) and neutralizing antibody (NA) was determined with micro CPE method.Two weeks after the full - course immunizadon, seroconversion rate for IFA was 100% in those sero - negative before immunizadon, and that for NA was 44.44% .after one year, the sero - conversion rate for IFA and NA were decreased to 28.57% and 14.80%, respectively. Two weeks after reinforce, positive rate of IFA and NA increased to 83.33% and 55.56% .So did the geometric mean titer (GMT) .Two years after reinforce, the positive rate of IFA and NA decreased to 22.5% and 26.0% .And four years after reinforce, the IFA still remained a high level but NA closed to zero. In the past four years, there are two cases of HRFS in the vaccinated group because of incomplete vaccination, but 26 cases in the control group.The ptotective rate is 94.01% .Also no severe side effect was observed except those regional induced by the cane sugar in the vaccine. Conclusion HFRS vaccine has good safety and effectiveness.The reinforce is necessary.