国产甲型肝炎灭活疫苗的安全性和免疫原性研究

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个，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1000U／0．5ml，史克疫苗剂量为每针720ELISAU／1ml。观察并比较两种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率。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％，100％和100％；史克疫苗为73％，80％和100％。国产疫苗抗体几何平均滴度分别为139．2mIU/ml、137．7mIU/ml和1066．7mIU/ml；史克必成疫苗分别为104．3mIU/ml、111．3mIU／ml和760．7mIU／ml。结论 国产甲肝灭活疫苗具有良好的安全性和免疫原性。

Safety and immunogenicity of a new inactivated hepatitis A vaccine

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.