流行性出血热沙鼠肾细胞灭活疫苗的现场评价  

A field study of inactivated vaccine against epidemic hemorrhagic fever

作　　者：汪美先[1] 李良寿[1] 孙长生[1] 曾蓉芳[2] 朱智勇[3] 赵斌成 宋新平 王海涛[1] 汪力亚[1] 张世忠[1] 庄礼业 徐志凯[1] 程卫青 

机构地区：[1]第四军医大学预防医学研究所 [2]卫生部上海生物制品研究所 [3]浙江省卫生防疫站 [4]兰州空军卫生防疫队

出　　处：《第四军医大学学报》1993年第2期81-84,共4页Journal of the Fourth Military Medical University

摘　　要：为比较沙鼠肾细胞灭活疫苗3个连续批号间和2个免疫程序间的免疫效果与安全性,作者于1992年3～6月在驻陕某军校学员与战士1186人中进行整群接种.其中550人分为5个抗体检测组(含1个安慰剂组).随机决定疫苗接种的批次和程序,仅91-32批按两个程序(0、7、28 d和0,30,60 d)各接种1个组,余均按0,7,28 d接种.另638人仅做反应观察.完成全程免疫的接种率为93.5％.接种反应率按人次计算为0.6％,反应轻,无异常反应,疫苗是安全的.用抗血凝素单克隆抗体ELISA与ELISA捕捉法检测了血清特异性HI与IgM抗体.3批疫苗(0,7,28d程序组)血清抗体阳转率[HI阳性和(或)IgM阳性]平均为49.5%(35.7％～53.8％),HI抗体的GMT分别为1:208,1:211与1:156,阳转率与GMT均无显著差异,表明疫苗生产工艺较稳定,91-32批2个免疫程序间免疫效果未示明显差别.而安慰剂组各种抗体阳转率均为0％,说明疫苗是有效的.To assess the safety and antibodies response of the three lots and two immunization procedures of inactivated vaccine prepared with Meriones unguicu/atus kidney cells infected with Z10 strain of EHFV by Shanghai Institute of Biological Products, a population vaccination trial was conducted among the students and soldiers of a military college in Shaanxi Province from March to June, 1992. Of 1 186 people, 550 were randomly divided into five groups. Blood samples were collected from the subjects before and after vaccination. Three groups were inoculated with one of the three lots on 0, 7, 28 d, respectively. Another group was vaccinated with lot 91-32 on 0. 30, 60 d, the rest with placebo on 0, 7, 28 d. The vaccination rate was 93.5%. All of the vaccinees were observed for inoculation reaction. The reaction rate was 0.6%. H1 and IgM antibodies were measured by McAb-ELISA and Mac-ELISA, respectively. The average seroconversion rate was 49.5% (35.7% ~53.8%). Geometric mean tiler (GMT) of HI antibody of three lots were 1 :208, 1 :211. 1 : 156, respectively. There was no significant difference in seroconversion rate and GMT between three lots. The results suggest that the preparation technology of the vaccine is reliable. No significant difference was found between the two procedures. The seroconversion rates of the antibodies in placebo group were 0%. It showed that these vaccines were eflective.

关 键 词：流行性出血热 疫苗 接种反应 

分 类 号：R186.3[医药卫生—流行病学]