国产冻干人用狂犬病纯化疫苗(Vero细胞微载体)的接种反应和免疫原性  

Adverse reaction and immunogenicity of domestic freeze-dried purified rabies vaccine(Vero cells)for human use

作　　者：吴金妍[1] 王琰[1] 储艳[1] 柴文清[1] 毛树宝 

机构地区：[1]上海生物制品研究所有限责任公司,上海200052

出　　处：《中国生物制品学杂志》2014年第12期1574-1578,共5页Chinese Journal of Biologicals

摘　　要：目的观察国产冻干人用狂犬病纯化疫苗（Vero细胞微载体）的接种反应和免疫原性。方法在山东省高密市按临床方案的入选标准选取年龄在10-60岁,身体健康,无犬伤史、狂犬病疫苗接种史及该疫苗接种禁忌证的志愿者,分Ⅰ、Ⅱ、Ⅲ期进行临床试验,按照免疫程序,接种国产冻干人用狂犬病疫苗,Ⅱ期临床试验以进口同类疫苗作为对照,进行接种反应和免疫原性观察。结果试验组疫苗接种后,不良反应发生率低,以人数计Ⅰ、Ⅱ、Ⅲ期不良反应发生率分别为6.1%、7.8%和7.7%,未见中、强反应,反应均为注射部位疼痛,不伴有局部红肿和硬结,为局部弱反应,未出现体温升高等全身反应,72 h时疼痛消失。Ⅱ、Ⅲ期临床免疫后,血清抗体阳转率14和45 d均为100%。试验组与对照组不良反应发生率和免疫后血清抗体阳转率差异均无统计学意义（P〉0.05）。结论国产冻干人用狂犬病纯化疫苗（Vero细胞微载体）接种反应轻微,且具有良好的免疫原性。Objective To observe the adverse reaction and immunogenicity of domestic freeze-dried purified rabies vaccine（Vero cells） for human use. Methods Healthy volunteers at ages of 10 - 60 years in Gaomi City,Shandong Province,without history of being bitten by dogs,rabies vaccination or contraindication of rabies vaccine,were selected for clinical trials of phases Ⅰ,Ⅱ and Ⅲ. The volunteers were inoculated with domestic freeze-dried rabies vaccine according to immunization schedule,and observed for safety and immunogenicity. Imported vaccine was used as control for phase Ⅱ trial. Results The adverse reaction rates based on cases in clinical trials of phases Ⅰ,Ⅱ and Ⅲ were 6. 1%,7. 8% and 7. 7% respectively. No moderate or severe adverse reaction was observed. All the reactions were local and mild pain in injection sites without redness,swelling or duration,which disappeared within 72 h. No systemic reactions such as fever were observed. Both the serum antibody positive rates 14 and 45 d after the first dose were 100% in trials of phases Ⅱ and Ⅲ. No significant differences were observed in adverse reaction rates and serum antibody positive conversion rates in trial and control groups（P 〉0. 05）. Conclusion Domestic freeze-dried purified rabies vaccine（Vero cells）for human use only caused mild adverse reactions,which showed good immunogenicity.

关 键 词：冻干人用狂犬病疫苗 VERO细胞 接种反应 免疫原性 

分 类 号：R373.9[医药卫生—病原生物学] R392-33[医药卫生—基础医学]