德国和印度生产的人用狂犬病疫苗（鸡胚细胞）的安全性和免疫原性
[Safety and immunogenicity of rabies vaccine (chick embryo cell) for human use produced in Germany and India].
作者信息
Zhu Feng-Cai, Wu Chuan-Hong, Meng Fan-Yue
机构信息
Jiangsu Provincial Center for Diseasial Control and Prevention, Nanjing 210009, Jiangsu, China.
出版信息
Zhongguo Yi Miao He Mian Yi. 2009 Oct;15(5):447-50.
OBJECTIVE
To evaluate the safety and immunogenicity of Rabipur produced in India.
METHODS
A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.
RESULTS
The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.
CONCLUSION
Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, "Medicine Clinical Experiment Written directive from a superior" 2005L04184.
目的
评估印度生产的人用狂犬病纯化疫苗（Vero细胞）的安全性和免疫原性。
方法
进行一项随机单盲研究，以比较安全性、效果和血清转化率。将德国生产的人用狂犬病纯化疫苗（Vero细胞）用作对照组。
结果
结果显示，试验组（印度生产的人用狂犬病纯化疫苗（Vero细胞））未出现严重的全身和局部反应。试验组与对照组之间的差异不显著。首剂接种后14天和45天，两组的血清转化率均为100%。首剂接种后14天和45天，两组的几何平均浓度（GMC）明显升高，且均远高于0.5TU/ml。
结论
印度生产的人用狂犬病纯化疫苗（Vero细胞）具有良好的安全性和免疫原性。试验注册号：国家食品药品监督管理局，“药物临床试验批件”2005L04184。
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