冻干甲型肝炎减毒活疫苗(H_(2)株)上市后临床Ⅳ期试验安全性及免疫原性评价  

Post-licensure evaluation on safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine(H_(2)strain)in clinical phaseⅣstudy

作　　者：程诚 钱汶 王龙龙 温佳楠 张涛 汪小东 丁利平 毛子安 CHENG Cheng;QIAN Wen;WANG Longlong;WEN Jianan;ZHANG Tao;WANG Xiaodong;DING Liping;MAO Zian(Zhejiang Pukang Biotechnology Co.,Ltd.,Hangzhou 310053,Zhejiang Province,China)

机构地区：[1]浙江普康生物技术股份有限公司,浙江杭州310053

出　　处：《中国生物制品学杂志》2025年第1期42-47,共6页Chinese Journal of Biologicals

基　　金：国家科技支撑计划课题(2008BAI66B04)。

摘　　要：目的评价冻干甲型肝炎减毒活疫苗(H_(2)株)上市后的安全性和免疫原性,以期作为免疫规划疫苗推广使用。方法对5000例18~24月龄健康婴幼儿接种1剂冻干甲型肝炎减毒活疫苗,观察接种后0~14 d的不良事件,其中200例入选免疫原性亚组,检测免疫前后8周血清中甲型肝炎病毒(hepatitis A virus,HAV)特异性IgG抗体水平。结果5000例完成入组接种,4999例完成安全性观察。报告征集性不良反应424例,不良反应发生率8.48%,征集性局部不良反应以接种部位红晕、触痛、瘙痒、皮疹、肿胀为主,征集性全身不良反应以发热、厌食为主,严重程度以1~2级为主,未发生与疫苗有关的严重不良事件。200例免疫原性亚组中有188例受试者纳入符合方案集(per protocol set,PPS),抗体阳转率为98.91%[95%可信区间(confidence interval,CI):96.11%~99.87%],HAV特异性IgG抗体几何平均滴度(geometric mean titer,GMT)为83.67 mIU/mL(95%CI:77.05~90.85 mIU/mL)。结论单剂冻干甲型肝炎减毒活疫苗(H_(2)株)对18~24月龄婴幼儿具有良好的安全性和免疫原性。Objective To assess the post-licensure safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine(H_(2)strain)in order to popularize it as an immunization program vaccine.Methods Totally 5000 healthy infants and young children aged 18-24 months were injected with single dose of freeze-dried live attenuated hepatitis A vaccine,and the adverse events of 0-14 d after vaccination were monitored.Among them,200 cases were selected into immunogenic subgroups,and the serum hepatitis A virus(HAV)specific IgG antibody(anti-HAV IgG)was measured 8 weeks before and after immunization.Results A total of 5000 participants completed inoculation,and 4999 participants completed safety observation,among which,424 cases of adverse reactions were reported,and the incidence of solicited adverse reactions was 8.48%.The common local solicited adverse reactions were redness,tenderness,itching,rash and swelling at the inoculation site,while the systemic adverse reactions were mainly fever and anorexia.The severity was mainly grade 1-2,and no serious adverse events related to the vaccine occurred.Among 200 immunogenic subgroups,188 participants were included in the per protocol set(PPS),the seroconversion rate of anti-HAV IgG antibody was 98.91%[95%confidence interval(CI):96.11%-99.87%],with a geometric mean titer(GMT)of 83.67 mIU/mL(95%CI:77.05-90.85 mIU/mL).Conclusion A single dose freeze-dried live attenuated hepatitis A vaccine(H_(2)strain)presents good safety and immunogenicity for infants and young children aged 18-24 months.

关 键 词：冻干甲型肝炎减毒活疫苗(H_(2)株) 临床试验 安全性 免疫原性 

分 类 号：R183.4[医药卫生—流行病学]