Poovorawan Y, Kosuwon P, Sutra S, Theamboonlers A, Vimolket T, Safary A
Department of Pediatrics, Chulalongkorn University Hospital, Bangkok, Thailand.
Asian Pac J Allergy Immunol. 1998 Jun-Sep;16(2-3):111-7.
An open study was performed to compare the reactogenicity and immunogenicity of an inactivated hepatitis A vaccine administered in two different doses and schedules to 460 healthy volunteers aged 3-18 years. Participants were randomized to two groups to receive either two doses of 720 ELISA Units (EL.U) inactivated hepatitis A per 0.5 ml dose according to a 0, 6-month schedule, or three doses of 360 EL.U according to a 0, 1, 6-month schedule. Transient local injection soreness was the most commonly reported symptom in almost half of both groups with no serious adverse events. One month after the primary course (one dose of 720 EL.U and two doses of 360 EL.U), 99% of 720 EL.U vaccinees had seroconverted, compared with 100% seroconversion in the 360 EL.U group. All vaccinees were seropositive after the booster dose of both vaccines with geometric mean anti-HAV titers of 2,359 and 2,967 mIU/ml in the 720 EL.U and 360 EL.U groups, respectively. The vaccine containing 720 EL.U of antigen per dose offers the advantage of convenience and acceptance of immunization afforded by a two-dose course of vaccination accompanied by a comparable antibody response with that achieved after three doses of vaccine containing 360 EL.U of antigen per dose.
一项开放性研究比较了两种不同剂量和接种程序的甲型肝炎灭活疫苗对460名3至18岁健康志愿者的反应原性和免疫原性。参与者被随机分为两组，一组按照0、6个月的程序接受两剂每0.5毫升含720酶联免疫吸附单位（EL.U）的甲型肝炎灭活疫苗，另一组按照0、1、6个月的程序接受三剂每剂含360 EL.U的疫苗。两组中近半数最常报告的症状都是短暂的局部注射疼痛，未出现严重不良事件。在基础免疫疗程（一剂720 EL.U和两剂360 EL.U）一个月后，720 EL.U疫苗接种者中有99%发生了血清转化，而360 EL.U组的血清转化率为100%。两种疫苗加强免疫后所有接种者均呈血清阳性，720 EL.U组和360 EL.U组的几何平均抗甲型肝炎病毒滴度分别为2359和2967 mIU/ml。每剂含720 EL.U抗原的疫苗具有优势，即两剂接种程序方便且易于接受，同时抗体反应与每剂含360 EL.U抗原的疫苗接种三剂后的反应相当。
