内科2025，Vol.20Issue(2)：153-157,5.DOI:10.16121/j.cnki.cn45-1347/r.2025.02.06
水痘减毒活疫苗两针免疫程序、加强免疫的血清学效果及大样本的安全性研究
Serological efficacy and large-sample safety study of two-dose immunization schedule and booster immunization with Varicella attenuated live vaccine
摘要
Abstract
Objective To evaluate the serological efficacy and large-sample safety of a two-dose immunization schedule and booster immunization with Varicella attenuated live vaccine(VarV).Methods The following study was performed from July 2016 to July 2021.(1)300 healthy children without prior VarV vaccination in Wuming were selected as the two-dose group,and 300 healthy children who had received one dose of VarV were selected as the booster group.Antibody titers before vaccination,42 days after the first dose,and 42 days after the second dose,as well as the immunization success rates of the two doses,were compared in the two-dose group.Antibody titers before and 42 days after the vaccination were compared in the booster group,and the immunization success rate was recorded.Adverse reactions within 3 days and 42 days after vaccination were observed in both groups.(2)A total of 53,626 healthy children from Hengzhou,Guiping,Fusui,and Ningming were recruited and divided into two-dose and booster groups for vaccination,with adverse reactions recorded within 30 days after vaccination.Results(1)After excluding dropouts in Wuming,281 children were actually included in the two-dose group and 297 in the booster group,with 887 vaccine doses evaluated for safety.In the two-dose group,the geometric mean titer(GMT,1∶)of antibodies was 19.95(95%CI:18.62-21.88)before vaccination,186.20(95%CI:173.78-204.17)after the first dose of vaccination,and 501.18(95%CI:469.73-549.54)after the second dose of vaccination;the increase folds were 9.33-fold(after the first dose of vaccination vs pre-vaccination),25.12-fold(after the second dose of vaccination vs pre-vaccination),and 2.69-fold(after the second dose of vaccination vs after the first dose),with statistically significant differences(all P<0.05).The immunization success rate was 86.83%after the first dose of vaccination and 98.93%after the second dose of vaccination in the two-dose group,with a statistically significant difference(P<0.05).In the booster group,the pre-vaccination antibody GMT was 44.66(95%CI:40.74-50.13),increasing to 338.99(95%CI:309.02-371.54)after vaccination,representing a 7.58-fold increase,with a statistically significant difference(P<0.05);the immunization success rate was 100%.Within 3 days after vaccination,14 adverse reactions occurred,including 8 systemic reactions(fever)(9.02‰)and 6 local reactions(redness/swelling at the injection site,rash,etc.)(6.76‰).Within 42 days after vaccination,25 adverse reactions occurred,including 14 systemic reactions(fever)(15.78‰)and 11 local reactions(redness/swelling at the injection site,rash,etc.)(12.40‰).(2)A total of 56,287 vaccine doses were administered to children in Hengzhou,Guiping,Fusui,and Ningming.Within 30 days after vaccination,35 adverse reactions(6.22 per 10,000)occurred,including 16 systemic reactions(fever)(2.84 per 10,000)and 19 local reactions(redness/swelling at the injection site,rash,etc.)(3.38 per 10,000).Conclusion Both the two-dose immunization schedule and booster immunization with VarV can improve protective efficacy with good safety,making them suitable for large-scale immunization in vaccination-aged children.关键词
水痘减毒活疫苗/两针免疫程序/加强免疫/安全性/大样本/儿童Key words
Varicella attenuated live vaccine/Two-dose immunization schedule/Booster immunization/Safety/Large sample/Children分类
预防医学引用本文复制引用
吕慧瑜,唐帅,秦卫文,刘霞,黄晓璐..水痘减毒活疫苗两针免疫程序、加强免疫的血清学效果及大样本的安全性研究[J].内科,2025,20(2):153-157,5.基金项目
广西壮族自治区疾病预防控制中心科研课题(201509 （）
202010) （）
