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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 ,分别为
Objective To observe and assess the safety, serological immunology and disease control efficacy of HFRS-1 mouse brain purified vaccine produced by Lanzhou Institute of Biological Products, and to determine the immunization program and immunization strategy. Methods The experimental group and the control group were grouped by random grouping method. The 1-dose immunization program was strengthened on 0, 7, 2 and 8 days and 1 year after the immunization. Two weeks after vaccination, Two weeks later, whole blood and trace earlobe blood were collected from partial vaccines of one, two, three, four and five years after the vaccination. The neutralizing antibodies and IFA antibodies were measured respectively. The immunological effects and on-site epidemiological effects of the vaccines were observed . Results During the 6 years between August 1995 and December 2001, the safety of the purified inactivated vaccine of HFRS-Ⅰ in mice was observed after immunization for 5 years and the serum immunological effects and Epidemiology and disease prevention effect. In summary, the results showed that the vaccine showed no serious side effects other than the more common and localized reactions caused by sucrose remaining in the vaccine, demonstrating that the vaccine has good safety. Serum immunization results showed that IFA antibody positive rate was 100% and neutralizing antibody positive rate was 444% (8/18) in serum of two weeks after inoculation. After 1 year, the positive rates of IFA antibodies and neutralizing antibodies decreased to 285.7% and 1480% respectively. However, the positive rates of serum IFA and neutralizing antibodies rebounded to 83 33% and 55 65% respectively two weeks after the boost, and the geometric mean titers of the antibody also rebounded but not obviously. In addition, the positive rates of IFA and neutralizing antibodies once again dropped to a lower level after 2 years of enhancement, respectively