【摘要】 目的“八五”、“九五”期间连续观察肾综合征出血热(Hemorrhagic Fever with Renal Syndrome,HFRS)沙鼠肾原代细胞Ⅰ型灭活疫苗(简称:沙鼠苗)、乳鼠脑纯化Ⅰ型灭活疫苗(简称:鼠脑苗)和地鼠肾原代细胞Ⅱ型灭活疫苗(简称:地鼠苗)在HFRS疫区试验人群中的安全性、血清学和流行病学效果,并提出免疫策略建议。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种疫苗安全性良好。在接种人群中的中强反应率较低;沙鼠苗为0.56％,地鼠苗1.57％,鼠脑苗3.26％。在接种疫苗的 168 714人中,6年内临床上未出现免疫(感染)增强反应的病例。接种组17例病人与对照组362例病人比较,临床类型差异无显著性(P>0.01)。119例疫苗接种者,以IFAT证实,再次自然感染汉坦病毒(HV)后,未出现临床症状。3种疫苗血清学效果较好。3种疫苗对人群保护效果均较高。免疫策略研究结果表明,同型苗用在同型疫区,Ⅱ型苗用在不同类型疫区和Ⅰ型苗用在姬鼠型为主混合型疫区,在观察的5年内均取得了满意的预防效果。结论我国研制的3种HFRS单价灭活疫苗,经过5年在高发疫区人群中的观察结果证明,安全有效,可以推广应用。并根据研究结果和本病流行特点提出了免疫策略的建议。更多还原

【Abstract】 The three kinds of vaccines were all safe with the moderate and severe side effects of vaccines 0.56%, 1.57%, 3.26% for Mongolian gerbils kidney vaccine, mouse brains vaccine, hamster kidney vaccine respectively.The antibody - dependent enhancement has not been found in 168 714 persons received vaccines after five years, with no differences statistically in clinical manifestations between 17 HFRS cases in vaccine group and 362 HFRS cases in control group ( P > 0.01) . The 119 inoculated individuals has not Shown any clinical symptoms after infected with hantavirus secondly, confirmed with IFAT.The positive rate of sampling detection for neutralizing antibody 14 day after fundamental immunity for three kinds of vaccines. one year before booster immunity for three kinds of vaceines, 14th day, two, three, four and five years after booster immunity for three kinds of vaccines is as follows respectively: 57.81%, 9.87%, 70.71%, 35.58%, 21.77%, 23.08%, 8.97% for Mongolian gerbils Kidney vaccine; 51.09%, 10.48%, 61.90%, 41.10%, 25.00%, 11.76%, 10.00% for Mouse brains vaccine; 82.46%, 12.33%, 80.13%, 53.39%, 37.04% , 30.77% , 18.75% for Hamster kidney vaccine.The three kinds of vaccines protection rate after fundamental immunity year by year is as follows respectivaly: 98.27%, 97.75%, 97.46%, 96.10%, 100.00%, year average 97.90% for Hamster kidney vaccine; 93.45%, 100.00%, 89.42%, 100.00%, year average 95.15% for Mouse brains vaccine; 95.56%, 91.72%, 93.83%, 83.55%, 100.00%, year average 94.50% for Mongolian gerbils kidney vaccine. The immunological strategy of these vaccines has showed that a satisfactory effects of prevention have been achieved for five year in the same endemic area by the same type of vaccine, in the different aendemic areas by type II vaccine in the mixed area by type I vaccine with the observation in the population of high prevalence area for five year, these vaccines can protect HFRS clinical infection effectively.更多还原