论文部分内容阅读
目的 现场验证HFRS-1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年的部分接种者全血和微量耳血,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者血清,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年平均保护率达94.01％。结论 现场观察结果证明该疫苗
Objective To verify the safety of HFRS-1 mouse brain purified vaccine, serum immunology and disease prevention. Methods According to random cluster sub-vaccination group, 9020 inoculation and 16203 in control group were inoculated. After 1, 2, 3, 4 and 5 years of intensive immunization, the immunization schedule of one dose was boosted at 0, 7, 28 and 1 year after immunization. Part of the vaccinated whole blood and trace ear fluid, were measured neutralizing antibodies and IFA antibodies. Results The field validation from August 1995 to December 2000 showed that HFRS-1 mice inactivated brain purified vaccines showed no serious reaction except for heavy and common local reactions due to residual sucrose in the vaccine Side effects, the vaccine proved good safety. Seen from the effect of serum immunization, the positive rate of IFA antibody was 100% in the sera of 86 immunized rabbits two weeks after inoculation, and the positive rate of neutralizing antibody was 44.44%. After 1 year, the positive rates of IFA antibodies and neutralizing antibodies decreased to 28.57% and 14.80% respectively. However, the positive rates of IFA antibody and neutralizing antibody rebounded to 83.33% and 55.56% respectively two weeks after the boost, and the geometric mean antibody titer (GMT) also rebounded but not obvious. In addition, the positive rates of IFA and neutralizing antibodies dropped again to 22.5% and 26.0% respectively 2 years after boosting, and almost all neutralizing antibodies disappeared 4 years after boosting, but IFA antibodies remained high The positive rate. In the vaccinated group, 1 case was inoculated with 2 needles, 1 had 3 inoculation and did not inoculate according to the prescribed procedures, so far no other cases occurred. In the control group, 26 cases had been reported and their 5-year average protection rate reached 94.01%. Conclusions The field observations demonstrate the vaccine