流行性出血热灭活疫苗人体试验的反应观察  

Reactive Observation of Inactivated Epidemic Hemorrhagic Fever Vaccine in Human Test

作　　者：朱智勇[1] 唐汉英[1] 李岩金[1] 翁景清[1] 付桂明[1] 俞永新[2] 姚小剑[2] 董关木[2] 安琪[2] 曾蓉芳[3] 陈松年[3] 王国梅[3] 沈伟[3] 

机构地区：[1]浙江省卫生防疫站自然疫源科,杭州310009 [2]中国药品生物制品检定所疫苗一室 [3]上海生物制品研究所病毒研究室

出　　处：《病毒学杂志》1990年第1期7-12,共6页

摘　　要：由流行性出血热(EHF)病毒浙_(10)株感染沙鼠肾细胞,经0.05％β-丙内酯灭活研制成的EHF灭活疫苗,于4℃放置7个月后,对10名志愿者免疫三针(0天、7天、28天各注射1ml)。结果免疫者的局部和全身均无任何副反应。首针免疫后第28天,血清用反向被动血凝抑制试验(RPHIA)、ELISA和间接免疫荧光试验(IFA)检测EHF抗体,分别有9人、9人和8人阳转,第42天,血清用三种方法检测抗体均全部阳转。空斑减少中和试验(PRNT)于第28天有4人阳转,第42天有9人阳转。上述结果表明,此疫苗对人体有较好的的安全性和免疫原性。Ten volunteers had been immunized intramuscularly(1 ml) three times at the 0, 7 and 28 days with the inactivatated(with 0.05%β-propiolactone) EHF Meriones unguiciculatus kidney culture vaccine with Z_(10) virus strain (kept at 4℃ for 7 months). The result showed that there had not been any side effects locally and generally in all of the volunteers. The EHF virus antibodies were detected in 9 and 8 volunteers with IFA and ELISA methods respectively and 9 volunteers were positive with RPHIA. And 4 volunteers turned positive on the 28th day(1 ml vaccinated twice)after the first immunization by PRNT. On the 42th day (1 ml vaccinated three times), EHF virus antibodies were positive in all volunteers with the methods of RPHIA, IFA and ELISA, while 9 of them were posivive with PRNT. The neutralization antibody GMT (geometrical mean titre) of the 9 volunteers is 1: 58.5. The result showed that it is reliable for the human being of the inactivated EHF vaccine with its safety and immunogenicity.

关 键 词：流行性出血热 灭活疫苗 人体试验 

分 类 号：R512.803[医药卫生—内科学]