德国产和印度产人用狂犬病疫苗(鸡胚细胞)瑞必补尔~的临床安全性和免疫原性研究

Safety and Immunogenicity of Rabies Vaccine(Chick Embryo Cell) for Human Use Produced in Germany and India

目的评价印度产人用狂犬病疫苗(鸡胚细胞)瑞必补尔[Rabies Vaccine(Chick Embryo Cell)for Human Use(Rabipur),RabV]的临床安全性和免疫原性。方法按随机、对照、盲法的原则,以德国产RabV作为对照,开展现场临床试验,比较试验疫苗和对照疫苗免疫后的安全性和免疫原性。结果印度产RabV无严重的全身和局部不良反应,试验疫苗和对照疫苗的全身和局部不良反应发生率差异无统计学意义。试验疫苗和对照疫苗首剂接种后第14d、45d,抗体阳转率均为100%。两组疫苗首剂接种后第14d、45d,抗体几何平均浓度远高于0.5国际单位/毫升的免疫保护水平。结论印度产RabV具有良好的安全性和免疫原性。临床试验注册国家食品药品监督管理局《药物临床试验批件》

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.