国产无明胶冻干水痘减毒活疫苗的安全性和免疫原性

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。

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

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.