Immunogenicity and safety of a new inactivated hepatitis A vaccine 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(英文)

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43-45,146-147,共5页中华医学杂志（英文版）

基　　金：ThisstudywassupportedbytheNationalKeyTechnologiesResearchandDevelopmentProgramNo (96 90 6 0 3 0 4 )

摘　　要：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 inactivat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　 1 0 4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1 0 0 0u的国产灭活疫苗 ,一组接种 50 0u的国产灭活疫苗 ,另一组接种 1 4 4 0ELISAu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 (GMT)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 ,1 0 0 0u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 0 0 1 ) ;6个月时 ,1 0 0 0u组的抗体阳转率为 96 9% ,高于 50 0u组的 65 0 % (P =0 0 0 2 9)和贺福立适组的 68 8% (P =0 0 0 7) ;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 2 64mIU/ml,高于贺福立适组的 1 3 5mIU/ ,l(P =0 .0 0 1 3 ) ;7个月时为 2 747mIU/ml,既高于贺福立适组的 1 3 1 6mIU/ml(P =0 .0 1 ) ,也高于 50 0u组的 1 67mIU/ml (p =0 0 2 2 4)。

关 键 词：hepatitis A · vaccine · immunogenicity · safety · adults 

分 类 号：R[医药卫生]