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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》2005L04184
Objective To evaluate the clinical safety and immunogenicity of Rabies Vaccine (Chick Embryo Cell) for Human Use (Rabipur), RabV]. Methods According to the principles of randomization, control and blinding, a German-made RabV was used as a control to carry out on-site clinical trials to compare the safety and immunogenicity of the test and control vaccines. Results RabV produced no serious systemic and local adverse reactions in India. There was no significant difference in the incidence of systemic and local adverse reactions between the experimental and control vaccines. At the 14th day and the 45th day after the first dose of the test vaccine and the control vaccine, the positive rate of the antibody was 100%. The geometric mean antibody concentration was much higher than the immune protection level of 0.5 IU / ml on the 14th and 45th day after the first vaccination. Conclusion Indian RabV has good safety and immunogenicity. Clinical trial registration State Food and Drug Administration “drug clinical trial document” 2005L04184