建德市肾综合征出血热Ⅰ型灭活疫苗的安全性及免疫效果研究  

A Randommized-controlled Field Trial of An Inactivated Vaccine(Type Ⅰ)against HFRS (Ⅰ: Summary)

作　　者：叶克龙 童政[1] 车焱[1] 张军[1] 刘兆麟 李永良[1] 周联娣[1] 陈丽华 汪群 方利红 

机构地区：[1]上海医科大学流行病学教研室,浙江省建德市卫生防疫站

出　　处：《中国媒介生物学及控制杂志》1996年第4期248-250,共3页Chinese Journal of Vector Biology and Control

摘　　要：采用以家庭为单位的随机对照设计，在以肾综合征出血热野鼠型为主的混合型疫区，考核肾综合征出血热沙鼠肾细胞灭活疫苗（Ⅰ型）的现场效果。全程接种７８６６人，接种反应轻微。接种后两周血清中和抗体阳转率为４８．０％，滴度为５．９５；血清ＥＬＩＳＡ抗体阳转率为８１．３％，１年后降为２４．０％，加强接种后两周回升为８７．０％。接种后１年，全程接种组无一病例发生，而全程对照组有９例病例，疫苗保护率为１００％（６０．５％～１００％）。To evaluate the safety, immunogenicity and protective efficacy of an inactivated vaccine, prepared from a Hantaan virus, cultured in primary gerbil kidney cell, a randommized-controlled field trial based on family randomization was carried out at an area endemic for hemorrhagic fever with renal syndrome(HFRS). 7866 cases received three basic-immunizations bv intramuscular with a vaccination schedule of 0, 7, 28 within one month. The reaction of the vaccine was slight. The seroconvertion rate of the neutralizing anti-Hantaan-virus was 48. 0 % , with 5. 95 geometric mean titres(GMT), and 81. 3 % seroconvertion rate of ELISA anti-Hantaan-virus, two weeks after the last vaccination. Just before the booster, a year after the basic-immunizations, the positive rate of ELISA antibody dropped to 24. 0 % . Two weeks after the booster, the positive rate increased to 87. 0 % . During the one year period, no HFRS case was found among the vaccinees who received the whole-schedule vaccinations, while 9 HFRS cases were confirmed in the control group, which were matched to the whole-schedule vaccinees. The protective efficacy of the tested vaccine was 100 % (60. 5 % - 100 % ). The result suggested that this inactivated vaccine against HFRS be safety and effective, it provide an useful method for the control of HFRS.

关 键 词：肾综合征出血热 灭活疫苗 免疫效果 安全性 

分 类 号：R512.803[医药卫生—内科学] R392-33[医药卫生—临床医学]