国产无明胶冻干水痘减毒活疫苗的安全性和免疫原性

Safety and immunogenicity of domestic gelatin-free freeze-dried live attenuated varicella vaccine

目的观察国产无明胶冻干水痘减毒活疫苗的安全性和免疫原性。方法采用随机、双盲、对照、多中心的方法,在广东省兴宁市、揭东县和梅县选择无水痘病毒暴露史的1~12岁健康儿童1 050名,分别接种国产的无明胶冻干水痘减毒活疫苗（试验组）及GlaxoSmithKline Biologicals S.A.（比利时）生产的冻干水痘减毒活疫苗（对照组）,进行为期6周的安全性观察;并对其中531名受试者采集免前和免后6周双份血样,采用膜抗原荧光抗体（Fluorescent antibody to membrane antigen,FAMA）法检测抗体水平,评价冻干水痘减毒活疫苗的免疫原性。结果试验组和对照组全身反应的总发生率分别为6.62%和8.06%,组间差异无统计学意义（P〉0.05）;局部反应的总发生率分别为4.35%和9.60%,组间差异有统计学意义（P〈0.01）;全身反应中以发热为主,局部反应中以疼痛和瘙痒为主,除瘙痒症状（P〈0.01）外,其他症状组间差异均无统计学意义。试验组和对照组免疫后抗体几何平均滴度（GMT）分别为1：126和1：140,组间差异无统计学意义（P〉0.05）;抗体阳转或免疫成功率分别为96.99%和96.98%,组间差异无统计学意义（P〉0.05）。结论与对照疫苗相比,在免疫原性相近的前提下,国产无明胶冻干水痘减毒活疫苗可能会降低过敏反应的发生率,具有更高的安全性。

Objective To observe the safety and immunogenicity of domestic gelatin-free freeze-dried live attenuated varicella vaccine.Methods A random,double-blinded control and multicenter trial was performed in 1 050 healthy children at ages of 1 ~ 12 years,who had no history of exposure to varicella virus and came from Xingning City,Jiedong County and Mei County of Guangdong Province.The children were inoculated with domestic gelatin-free freeze-dried live attenuated varicella vaccine,using imported vaccine as control,and observed for safety for 6 weeks.Serum samples were collected from 531 of the children and determined for antibody levels before and 6 weeks after inoculation with fluorescent antibody to membrane antigen（FAMA）,based on which the immunogenicity of domestic vaccine was evaluated.Results The systemic adverse reaction rates in trial and control groups were 6.62% and 8.06% respectively,which showed no significant difference（P 0.05）.However,the local adverse reaction rates were 4.35% and 9.60% respectively,which showed significant difference（P 0.01）.The symptoms of systemic reactions were mainly fever,while those of local reactions were mainly pain and pruritus.The occurrence rates of the symptoms,except pruritus（P 0.01）,showed no significant difference in trial and control groups.The GMTs of antibodies in trial and control groups after inoculation were 1 ∶ 126 and 1 ∶ 140 respectively,which showed no significant difference（P 0.05）.The antibody positive conversion / successful immunization rates in trial and control groups were 96.99% and 96.98% respectively,which showed no significant difference（P 0.05）.Conclusion The immunogenicity of domestic gelatin-free freeze-dried live attenuated varicella vaccine was comparable to that of imported vaccine,while the anaphylactic reaction rate decreased,indicating a higher safety.