Guan R, Ng H S, Fock K M, Ho K Y, Yap I, Kang J Y, Chow W C, Chew C N, Ng C, Teo C J
Department of Medicine, National University Hospital, Singapore.
Southeast Asian J Trop Med Public Health. 1995 Jun;26(2):268-71.
The immunogenicity and reactogenicity of an inactivated hepatitis A virus (HAV) vaccine was studied in healthy Singaporean adult volunteers. One hundred and forty healthy volunteers with normal alanine (ALT) and aspartate (AST) transaminases and no previous exposure to HAV, received three 1 ml doses (720 ELISA units) of an inactivated HAV vaccine (Smithkline Beechams Biologicals) following a 0, 1, 6 months vaccination schedule. All subjects were asked to record and grade the severity of any reactions for three consecutive days after each dose. Serum ALT and AST as well as anti-HAV were measured at 0, 1, 2, 6 and 7 months after the first vaccine dose. Anti-HAV seroconversion occurred when levels rose above 40 mIU/ml. Eighty-five percent of vaccinees seroconverted after the first innoculation and 99% after the second injection. All vaccinees seroconverted after the third dose. Geometric mean anti-HAV titers (GMTs) were, respectively, 119, 391, 4406 mIU/ml one month after each of the three doses. The most common side effect was transient pain and tenderness at the vaccination site. No elevation of ALT or AST levels were noted during the study period. The inactivated hepatitis A vaccine used in this study is safe and highly immunogenic in the local adult population. Two doses one month apart appeared to give adequate protection.
在健康的新加坡成年志愿者中研究了一种甲型肝炎病毒(HAV)灭活疫苗的免疫原性和反应原性。140名丙氨酸转氨酶(ALT)和天冬氨酸转氨酶(AST)正常且既往未接触过HAV的健康志愿者,按照0、1、6个月的接种程序,接种了3剂1毫升(720酶联免疫吸附测定单位)的HAV灭活疫苗(史克必成生物制品公司生产)。要求所有受试者在每次接种后连续三天记录并对任何反应的严重程度进行分级。在首次接种疫苗后的0、1、2、6和7个月测量血清ALT、AST以及抗-HAV。当抗-HAV水平升至40 mIU/ml以上时发生血清转化。85%的接种者在首次接种后发生血清转化,第二次注射后为99%。所有接种者在第三次接种后均发生血清转化。在三次接种后的每个月,几何平均抗-HAV滴度(GMT)分别为119、391、4406 mIU/ml。最常见的副作用是接种部位短暂的疼痛和压痛。在研究期间未观察到ALT或AST水平升高。本研究中使用的甲型肝炎灭活疫苗在当地成年人群中安全且具有高度免疫原性。间隔一个月接种两剂似乎能提供足够的保护。