国产甲型肝炎灭活疫苗的安全性和免疫原性研究  

Safety and immunogenicity of a new inactivated hepatitis A vaccine

作　　者：任爱国[1] 马俊荣[1] 冯福民[1] 徐应军[1] 刘崇柏[2] 

机构地区：[1]华北煤炭医学院预防医学系流行病学教研室,唐山063000 [2]中国预防医学科学院病毒学研究所肝炎研究室

出　　处：《中华实验和临床病毒学杂志》2001年第4期357-359,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：国家九五医学科技攻关项目 (96-90 6-0 3 -0 4)

摘　　要：目的　评价一种国产甲型肝炎 (甲肝 )灭活疫苗对人体的安全性和免疫原性。方法　为Ⅰ期临床试验。 31名对甲肝易感的成年人被随机分为两组 ,实验组 16人 ,接种国产甲肝灭活疫苗 ,对照组 15人 ,接种史克必成公司生产的甲肝灭活疫苗。按 0、3程序进行接种。国产疫苗剂量为每针10 0 0U 0 .5ml,史克疫苗剂量为每针 72 0ELISAU 1ml。观察并比较两组接种后的局部和全身反应以及接种后 1、3、4个月血清抗体阳转率和滴度。结果　两组初免和加强接种后个别接种对象表现轻微局部或全身反应 ,未发现肝功能损害。初次免疫后 1个月、3个月和加强后 1个月 ,国产疫苗的抗体阳转率分别为 94% ,10 0 %和 10 0 % ;史克疫苗为 73% ,80 %和 10 0 %。国产疫苗抗体几何平均滴度分别为 139 2mIU ml、137 7mIU ml和 10 6 6 7mIU ml;史克必成疫苗分别为 10 4 3mIU ml、111 3mIU ml和76 0 7mIU ml。Objectives To evaluate the safety and immunogenicity of a new inactivated hepatitis A virus (HAV) vaccine.Methods In a randomized controlled trail thirty\|one HAV\|seronegative adults were enrolled and randomly assigned to either study group or control group.Subjects in the study group were given 1 000 units of the new inactivated HAV vaccine,with a booster at 3 months.Subjects in the control group were given 720 ELISA units Havrix,produced by SmithKline Beecham Biologicals,with a subsequent dose at 3 months.Local and systematic reactions and serum response to the vaccines were compared between the two groups.Results Mild local reactions were noted in one subject from the study group and two from the control group after primary vaccination.Mild systematic reactions were reported in two subjects from each group after primary vaccination and in one subject from the study group after booster vaccination.Seroconversion rates were 94%,100%,and 100% in the study group at 1,3,and 4(1 month after booster)months,respectively.The corresponding figures were 73%,80% and 100% in the control group.Geometric mean antibody titers were 139.2 mIU/ml,137.7 mIU/ml,and 1 066.7 mIU/ml at 1,3,and 4 months,respectively,in the study group,and 104.3 mIU/ml,111.3 mIU/ml,and 760.7 mIU/ml in the control group.Conclusion The new inactivated hepatitis A vaccine was safe and highly immunogenic.

关 键 词：甲型肝炎 灭活疫苗 安全性 免疫原性 Ⅰ期临床试验 

分 类 号：R392-33[医药卫生—免疫学]