Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K
Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium.
J Med Virol. 2001 Sep;65(1):6-13.
It is important to monitor the long-term persistence of antibodies induced by vaccination. Four cohorts were followed for their long-term immunity after vaccination with a combined hepatitis A and B vaccine (Twinrix; SmithKline Beecham Biologicals, Rixsenart, Belgium). Two cohorts of adults (ages 17-60 years), one of 1-6-year-olds, and one of 6-15-year-olds were vaccinated following a 0, 1, and 6-month schedule. Follow-up data until month 72 (adults) and month 60 (children) are available. At month 72, antibody to hepatitis A virus (anti-HAV) seropositivity (S+) was 100% for both adult cohorts (n = 40 and n = 47) and 95% and 89% of the vaccinees were seroprotected against hepatitis B virus (HBV), respectively. The geometric mean titres (GMTs; mIU/ml) for anti-HAV were 977 and 542 and the GMTs for the antibody to hepatitis B surface antigen (anti-HBs) were 322 and 90. For 1-6-year-olds at month 60 (n = 39), anti-HAV S+ was 100% with a GMT of 479 and 97% were protected against HBV with a GMT of 195. At month 60 for the 6-15-year-olds (n = 42), anti-HAV S+ was 100% with a GMT of 990 and 95% were protected against HBV with a GMT of 263. There have been no safety issues during the follow-up. In the past 5 years, a postmarketing surveillance system was available. Using this system, all spontaneous adverse events are collected and archived. Although infrequent, the most commonly reported adverse events after more than 13 million doses were allergic-type reactions followed by fever and injection site reactions. The combined hepatitis A and B vaccine is safe and is well tolerated. Immunity provided by the vaccine remains high in adults and children with comparable results to those obtained with monovalent vaccines.
监测疫苗诱导产生的抗体的长期持续性很重要。对四个队列接种甲型和乙型肝炎联合疫苗（安在时；史克必成生物制品公司，比利时里克森萨特）后的长期免疫力进行了跟踪研究。两个成人队列（17 - 60岁）、一个1 - 6岁儿童队列和一个6 - 15岁儿童队列按照0、1和6个月的接种程序进行了接种。现有直至第72个月（成人）和第60个月（儿童）的随访数据。在第72个月时，两个成人队列（n = 40和n = 47）中甲型肝炎病毒抗体（抗 - HAV）血清阳性率（S +）均为100%，分别有95%和89%的接种者对乙型肝炎病毒（HBV）具有血清保护作用。抗 - HAV的几何平均滴度（GMTs；mIU/ml）分别为977和542，乙型肝炎表面抗原抗体（抗 - HBs）的GMTs分别为322和90。对于1 - 6岁儿童，在第60个月时（n = 39），抗 - HAV S +为100%，GMT为479，97%的儿童对HBV具有保护作用，GMT为195。对于6 - 15岁儿童，在第60个月时（n = 42），抗 - HAV S +为100%，GMT为990，95%的儿童对HBV具有保护作用，GMT为263。随访期间未出现安全问题。在过去5年中，有一个上市后监测系统。利用该系统，收集并存档了所有自发不良事件。虽然不常见，但在超过1300万剂疫苗接种后，最常报告的不良事件是过敏型反应，其次是发热和注射部位反应。甲型和乙型肝炎联合疫苗安全且耐受性良好。该疫苗在成人和儿童中提供的免疫力仍然很高，与单价疫苗获得的结果相当。
