中国媒介生物学及控制杂志

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安徽省肾综合征出血热Ⅰ型灭活疫苗的安全性、免疫性评价及其流行病学效果考核

罗兆庄1; 刘红1; 王以银1; 任次早1; 戴振威1; 宋明宇2; 吴炳权3; 韩远荣4; 俞正楚1; 张大荣1; 魏强2; 黄玉有4; 谢杰3; 陈家新2   

  1. 1.安徽省卫生防疫站 合肥 230061;2.霍邱县卫生防疫站;3.颖上县卫生防疫站;4.六安市卫生防疫站
  • 出版日期:1996-08-20 发布日期:1996-08-20

Evaluation of Safty, Immunity and Epidemiological Effects of Inactivated HFRS Vaccine Ⅰ Cultured in M. unguiculatus Kidney Cell

Luo Zhao-zhuang;Liu Hong;Wang Yi-yin et al   

  • Online:1996-08-20 Published:1996-08-20

摘要: 采用流行病学、血清学和病原学方法对我省出血热重点流行区的类型进行了调查,明确是以姬鼠型为主的疫区。为此,选择HFRS沙鼠肾细胞Ⅰ型灭活疫苗为本次观察考核的疫苗。对人间疫情和鼠间感染情况进行多次监测,确定淮河流域上段HFRS稳定的重疫区为试点,并按发病率和估计疫苗的保护率确定了试点样本含量。共确定2万余人为观察对象,经个体随机方法,确定了接种组和对照组,经均衡试验检测P>0.05,两组选择是满意的。经过1年观察,该苗有良好的抗原性,全程接种后14天IFA抗体阳转率达95.15%(58/62),GMT为32.38,抗体水平持续3~6个月,首次接种后360天加强注射阳转率亦可达90%以上;McPENT抗体阳转率仅为54.17%(13/24),GMT为16.16。10793人全程接种后未发现全身严重异常反应,反应率在1.0%以下,对人群是安全的,并有良好的免疫应答;在1年观察中接种组无一例患者发生,对照组发病率为123.8/10万,保护率为100%,证实近期流行病学防病效果非常理想。

关键词: 肾综合征出血热, 疫苗, 保护率

Abstract: An investigation on HFRS foci pattern was conducted in Anhui province by means of epidemiology, serology and etiology. It showed that the province mainly belonged to wild rodent epidemic area(type Ⅰ), on which inactivated HFRS vaccine Ⅰ cultured in M. unguilatus kidney cell was selected in the study.The research was taken up in the epidemic area of up Huai River of the province, according to several surveillance of population prevalence and rodent's infection of HFRS viruses. The sample size was calculated on HFRS incidence rate and protection rate of the vaccine. More than 20, 000 persons were selected as trial population and randomly divided into inoculation and control groups who were parallel by statistic test(P>0. 05). The vaccine had good antigen during one year's observation. The rate of the vaccine-induced antibody was 95. 15 %( 59/62 ) after third injection(GMT=32.38). IFA antibody existed 3 to 6 months, and the positive rate of the inoculation group was more than 90 % on 360th day after third injection. The positive rate of neutralization was 54. 17 %(13/24) by MCPENT, GMT was 16. 16. There was no severe innormal reaction in 10793 recipients of inoculation program, the reaction rate was below 1 %. The vaccine was safe and had good immuno response. During one year's observation there was no HFRS case in run-in group and the incidence rate of the controls was 123.87/100,000,the protection rate was 100 %. The result showed the epidemiological effect was satisfied in short period.