福氏2a痢疾结合疫苗临床安全性和免疫原性研究  

Evaluation on the Safety and Immunogenicity of Shigella Flexneri 2a Conjugate Vaccine

作　　者：陈昌标[1] 周伟忠[2] 姜仁杰[3] 赵国雄[4] 顾建祥[1] 周锦国[1] 赵志强[5] 

机构地区：[1]射阳县疾病预防控制中心,江苏射阳224300 [2]江苏省疾病预防控制中心,南京210009 [3]盐城市疾病预防控制中心,江苏盐城224002 [4]中国药品生物制品检定所,北京100050 [5]兰州生物制品研究所,甘肃兰州730046

出　　处：《中国疫苗和免疫》2008年第2期133-137,共5页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价福氏2a痢疾结合疫苗临床安全性和免疫原性。方法按随机、对照、盲法的原则,以不含福氏2a痢疾结合疫苗成份的磷酸缓冲盐水作为安慰剂对照,开展现场临床试验,比较试验疫苗组和对照组免疫后临床反应、抗体阳转率和几何平均滴度(GMT)增长倍数。结果福氏2a痢疾结合疫苗无严重的全身和局部反应,试验疫苗组和对照组全身和局部反应发生率差异无显著的统计学意义。试验疫苗组经2针全程免疫后2周和12周,抗体阳转(≥4倍增长)率分别为86.27%和79.74%;GMT分别为1:3783.55和1:2983.32;抗体GMT较免疫前分别平均增长12.47倍和9.83倍。而对照组2针免疫后2周和12周,抗体阳转(≥4倍增长)率分别为8.18%和8.49%;GMT分别为1:361.83和1:326.21;抗体GMT较免疫前分别平均增长1.08倍和0.98倍。全程免疫后试验疫苗组与对照组抗体阳转率、GMT、抗体滴度,较免疫前平均增长倍数差异均有非常显著的统计学意义。结论福氏2a痢疾结合疫苗是安全的,在≥2岁的观察者中有良好的免疫原性。临床试验注册国家食品药品监督管理局《药物临床试验》2003L03808号。Objective To evaluate the safety and immunogenicity of Shigella flexneri 2a conjugate vaccine. Methods A random and double blind study were carried out to compare the safety sero conversion rates and geometric mean titer（GMT）increase of Shigella flexneri 2a conjugate vaccine with phosphate-buffered saline used as control. Results The results showed that no severe systemic and local reaction rates occurred in trial group, which were not statistically significant compared with the control group. The seroconversion rate of both two weeks and twelve weeks after two doses （increased by 4 folds） were 86.27% and 79. 74% ;for GMT were 1 ： 361.83 and 1 ： 326.21 and increased averagely 1.08 and 0. 98 times, which showed significant difference with those of the control group. Conclusion Shigella flexneri 2a conjugate vaccine was safe and its immunogenicity was good in group over 2 years old. Trialregistration National food drugs surveillance admin- istrative bureau, ＂Medicine Clinical Experiment Written directive from a superior＇2003L03808 number.

关 键 词：福氏2a痢疾结合疫苗 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学] R516.4[医药卫生—公共卫生与预防医学]