国产和进口冻干水痘减毒活疫苗的安全性和免疫原性评价研究

Study on Safety and Immunogenicity of Imported and Domestic Varicella Attenuated Live Vaccine(Freeze-dried) for Children

目的评价国产和进口冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)的安全性和免疫原性。方法选择118名7～13岁的健康水痘易感者,采用随机、双盲、对照临床试验,分成接种进口和国产VarV-Fd组,收集接种后不同时间点的不良反应以及免疫后6周的血清,采用膜免疫荧光方法检测抗体。结果国产VarV-Fd接种1剂后未报告局部和全身不良反应,免疫后抗体阳性率达100%,几何平均滴度(Genometric Mean Titer,GMT)1∶205.54,较免疫前GMT增长36.8倍。进口VarV-Fd接种1剂后,报告2例轻度局部不良反应,抗体阳性率也达100%,GMT为1∶203.98,较免疫前GMT增长27.6倍。经统计学检验,免疫后两组GMT差异无统计学意义(t=0.034,P=0.973)。结论国产和进口VarV-Fd均有良好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of imported and domestic freeze-dried varicella attenuated live vaccines. Methods 118 healthy varicella susceptibles of 7-13 years-old were involved randomly into two groups, and inoculated by domestic and imported varicella vaccines respectively. Adverse reactions were observed at different time points after immunization, and serums were collected to measure antibody level after 6 weeks. Results No local or systemic adverse reaction was observed in the group of domestic varicella vaccine, but two slight local adverse reactions were observed in the group of imported varicella vaccine, and the antibody positive rate in two groups was 100% equally. After immunization, geometric mean titer of antibody was 1∶205.54 and 1：203.98 in the group of domestic and imported varicella vaccine, which increased 36.8 and 27.6 times than preimmune, respectively. No statistically differences were found in vaccine-induced antibody levels between two groups（t=0.034,P=0.973）. Conclusion Domestic and imported varicella vaccines had good safety and immunogenicity equally.