Immunogenicity and safety of a new inactivated hepatitis A vac cine in young adults: a comparative study  

国产甲型肝炎灭活疫苗的免疫原性和安全性的比较研究

作　　者：任爱国[1] 冯福民[1] 马俊荣[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,北京,100083 [2]中国预防医学科学院病毒学研究所肝炎研究室,北京,100052

出　　处：《Chinese Medical Journal》2002年第10期1483-1485,共3页中华医学杂志（英文版）

摘　　要：OBJECTIVE: To evaluate the immunogenicity, safety, and dosage of a new inactivated hepatitis A vaccine administered to young adults. METHODS: One hundred and four normal adult volunteers, seronegative for hepatitis A virus and hepatitis B surface antigen, were randomly assigned to one of three groups. The high-dose group received a primary dose of 1000 units of the new vaccine, the low-dose group received a primary dose of 500 units of the same vaccine, and the Havrix group received a primary dose of 1440 enzyme-linked immunosorbent assay units of Havrix, a licensed inactivated hepatitis A vaccine. All groups received a booster dose of the same vaccine 6 months after the primary dose. Local and systemic adverse reactions, seroconversion rates, and geometric mean titers of hepatitis A virus antibodies were measured in all three groups. RESULTS: Local and systemic reaction types and rates were similar in all three groups after primary and booster doses, although local reactions were more frequent in the Havrix group following the primary dose. No serious adverse reactions occurred. One month after the primary dose, the seroconversion rate was 87.5% in the high-dose group, 70.0% in the low-dose group, and 50.0% in the Havrix group (P = 0.001, versus the high-dose group). At month 6 (before administration of the booster dose), seroconversion rates were 96.9% in the high-dose group, 65.0% in the low-dose group (P = 0.0029), and 68.8% in the Havrix group (P = 0.007). All subjects in all groups seroconverted by one month after receipt of the booster dose. Geometric mean titers were similar in all three groups at month 1, but were higher in the high-dose group (264 mIU/ml) than those in the Havrix group (135 mIU/ml) at month 6 (P = 0.0013). One month after the booster dose, geometric mean titers in the high-dose group (2747 mIU/ml) were higher than those in the low-dose group (1657 mIU/ml) (P = 0.0223) or in the Havrix group (1316 mIU/ml) (P = 0.01). CONCLUSIONS: This new inactivated hepatitis A vaccine is immunogenic an目的评价一种国产甲型炎灭活疫苗对我国成年人的免疫原性、安全性和适宜剂量.方法 104名甲肝抗体阴性、乙肝表面抗原阴性、血清谷丙转氨酶正常的成年志愿者被随机分为三组:一组接种 1000u 的国产灭活疫苗,一组接种 500u 的国产灭活疫苗,另一组接种 1440 ELISA u 的贺福立适甲肝灭活疫苗.所有三组均在初免后6个月时加强免疫一次.对三组间的局部和全身反应、血清甲且抗体阳转率以及抗体几何平均滴度 (GM T) 进行比较.结果虽然贺福立适组在初免后局部反应销多,在初免和加强免疫后,三个组的局部和全身反应发生频率基本相似.末观察到严重的局部和全身反应.初免后一个月时 ,1000u 组的甲且抗体阳转率为 87.5%, 高于贺福立适组 50.0% 的抗体阳转率 (P=0 .001); 6个月时,1000u 组的抗体阳转率为 96.9%,高于 500u 组的 65.0% (P=0. 0029) 和贺福立适组的 68.8% (P=0.007);7个月(加强免疫后一个月)时,所有接种对象全部阳转.三组在初免后一个月时,抗体GMT为 264mIU/ml, 高于贺福立适组的 135m IU/,l (P=0.0013);7个月时为 2747mIU/ml,既高于贺福立适组的 1316mIU/ml(P= 0.01),也高于500 u 组的 167mIU/ml (p=0.0224).结论国产甲肝灭活疫苗免疫原性良好并且是安全性的,成人每次接种 1000 u,按0,6月程序接种可以提供很好的保护作用.

关 键 词：Adolescent Adult Comparative Study Hepatitis A Vaccines Humans Research Support  Non-U.S. Gov't Vaccines  Attenuated 

分 类 号：R969[医药卫生—药理学]