冻干甲型肝炎减毒活疫苗在18~24月龄儿童中接种的免疫原性及安全性评价  

Safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine in children at ages of 18~24 months

作　　者：董媛媛 王辰皓 徐艳玲 赵淑洁 夏强 姜崴 胡伟军[1] 郭雪 DONG Yuan-yuan;WANG Chen-hao;XU Yan-ling;ZHAO Shu-jie;XIA Qiang;JIANG Wei;HU Wei-jun;GUO Xue(Shaanxi Center for Disease Control and Prevention,Xi’an 710054,Shaanxi Province,China;不详)

机构地区：[1]陕西省疾病预防控制中心,陕西西安710054 [2]长春生物制品研究所有限责任公司,吉林长春130012

出　　处：《中国生物制品学杂志》2021年第12期1456-1462,共7页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划项目(20190404001YY,201603007YY)。

摘　　要：目的评价工艺优化后的冻干甲型肝炎减毒活疫苗在18~24月龄儿童中接种的免疫原性及安全性。方法采用单中心、随机、平行对照的非劣效试验,在陕西省勉县和洋县选择18~24月龄的儿童450名,按照1∶1∶1分别接种1剂试验疫苗(长春生物制品研究所有限责任公司生产的冻干甲型肝炎减毒活疫苗)或两种对照疫苗(其他厂家生产的冻干甲型肝炎减毒活疫苗)。所有受试者于免疫前、免疫后30 d采集静脉血,分离血清,检测甲型肝炎病毒总抗体,并计算抗体阳性率、阳转率。观察并记录所有受试者免疫后30 min、0~7 d、8~30 d内的不良事件(adverse events,AEs),并随访至免疫后6个月。结果接种1剂试验疫苗或对照疫苗后,试验组免疫后抗体阳性率和阳转率非劣效于两个对照组。试验组、对照组1、对照组2总AE发生率分别为20.00%、22.15%和24.00%,全身反应发生率分别为12.00%、14.09%和16.00%,局部反应发生率分别为1.33%、1.34%和0.67%。试验组和两个对照组AE发生率差异无统计学意义(P>0.05)。结论长春生物制品研究所有限责任公司工艺优化后生产的冻干甲型肝炎减毒活疫苗在18~24月龄儿童中免疫效果和安全性良好,适合推广使用。Objective To evaluate the immunogenicity and safety of freeze-dried live attenuated hepatitis A vaccine(HepA-L)after optimization of process in children at ages of 18~24 months.Methods A single center,randomized,parallel controlled non-inferiority trial was performed.A total of 450 children at ages of 18~24 months were selected in Mian County and Yang County,Shaanxi Province,China and evenly divided into three groups at a ratio of 1∶1∶1.The children in trial group were immunized with one dose of HepA-L vaccines manufactured by Changchun Institute of Biological Products Co.,Ltd.,while those in two control groups with the HepA-L manufactured by other two manufacturers respectively.Venous blood samples were collected before and 30 d after immunization,from which serum samples were separated and determined for the total antibody level to hepatitis A virus,and the seropositive rate and seroconversion rate were calculated.Adverse events(AEs)within 30 minutes,0~7 d and 8~30 d after immunization were observed and recorded,and followed up to 6 months after immunization.Results Both the seropositive rate and seroconversion rate of antibody in trial group were non-inferior to those in the two control groups.The total incidences of AEs in trial group,control group 1 and control group 2 were 20.00%,22.15%and 24.00%,while the incidences of systemic reactions were 12.00%,14.09%and 16.00%,and those of local reactions were 1.33%,1.34%and 0.67%,respectively.There was no significant difference in the incidences of AEs in the trial group and the two control groups(P>0.05).Conclusion The Hep-L vaccine manufactured by Changchun Institute of Biological Products Co.,Ltd.shows good immune effect and safety in children at ages of 18~24 months.

关 键 词：甲型肝炎疫苗 免疫原性 安全性 

分 类 号：R186.3[医药卫生—流行病学]