流感嗜血杆菌结合疫苗临床安全性及免疫原性研究  

Evaluation of safety and immunogenicity of Haemophilus influenza type b conjugate vaccines

作　　者：潘红星[1] 张艺飓[1] 陈帅 顾善坤 梅茂冬 张盐姝 朱叶江 蒯云 朱凤才[1] 

机构地区：[1]江苏省疾病预防控制中心,江苏南京210009 [2]滨海县疾病预防控制中心,江苏盐城224500

出　　处：《中华疾病控制杂志》2009年第6期663-666,共4页Chinese Journal of Disease Control & Prevention

摘　　要：目的评价国产流感嗜血杆菌结合疫苗的安全性和免疫原性。方法按整群随机抽样原则,以国产同类疫苗作为对照开展现场临床研究;比较试验和对照疫苗免后不良反应率、抗-Hib阳转率、保护率、免后抗-Hib水平(GMT)和免后抗-Hib较免前平均增长倍数。结果试验组及对照组接种后总体不良反应率分别为26.00%和22.67%,差异无统计学意义(P>0.05);在安全性观察期内,所观察到的不良反应以1、2级不良反应为主,未观察到3级以上不良反应。免后抗体总阳转率分别为98.52%和98.37%,试验疫苗和对照疫苗免后阳转率差异无统计学意义(P>0.05);两疫苗免后保护率、免后抗-Hib GMT和免后抗-Hib较免前平均增长倍数差异均无统计学意义(P>0.05)。结论受评的该国产流感嗜血杆菌结合疫苗总体不良反应与国产同类疫苗差异无统计学意义,免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的临床安全性和免疫原性。Objective To evaluate the safety and immunogenicity of Haemophilus influenza type b conjugate vaccines. Methods Samples were chosen by cluster and random method, and divided into trial group（administrated Hib conjugate vaccine made in Chengdu Biological Product Institute, China） and control group （administrated Hib conjugate vaccine made in Lanzhou Biological Product Institute, China）. Results After immunization, the general adverse event of trial group and control group did not appeared statistically significant （26.00% vs 22.67% , P 〉 0.05）. The antibody positive rates of trial and control groups did not appeared statistically significant （98.52 % vs 98.37% , P 〉0.05）, the antibody protective rate, GMT and average increased times also did not appeared statistically significant. Conclusions Haemophilus influenza type b conjugate vaccine made in Chengdu Biological Product Institute its safety and immunogenicity were as good as homo vaccine made in Lanzhou Biological Product Institute.

关 键 词：嗜血菌 流感 疫苗 安全 

分 类 号：R378.4[医药卫生—病原生物学]