Lee S D, Chan C Y, Yu M I, Wang Y J, Chang F Y, Lo K J, Safary A
Department of Medicine, Veterans General Hospital-Taipei, Taiwan, ROC.
J Med Virol. 1999 Sep;59(1):1-4.
This open, randomized study was conducted in healthy Chinese youngsters, aged between 10 and 19 years to compare the reactogenicity and immunogenicity of two vaccines: the combined vaccine against hepatitis A and B was administered in a two-dose schedule with the profile of the corresponding monovalent vaccines, while the concomitant vaccine was administered also on a two-dose schedule but simultaneously in opposite arms. All vaccinees had antibodies against hepatitis A (anti-HAV) after the 2-dose administration, whereas all but four in the first and two in the second group had protective titres against hepatitis B (anti-HBs). At month 7, the geometric mean titres for both antibodies were more than double for the group of subjects receiving the combined vaccine: 3,701 vs. 1,705 mIU/ml for the anti-HAV, and 1,524 vs. 720 mIU/ ml for the anti-HBs response. Injection site pain was the most commonly reported local symptom and headache was the most reported general symptom. It is concluded that this combined vaccine against hepatitis A and B, administered according to a two-dose schedule, is well-tolerated and highly immunogenic.
这项开放性随机研究在10至19岁的健康中国青少年中进行，以比较两种疫苗的反应原性和免疫原性：甲乙肝联合疫苗按两剂程序接种，接种方案与相应单价疫苗相同，而联合疫苗也按两剂程序接种，但同时在双臂不同部位接种。所有接种者在两剂接种后均产生了抗甲型肝炎抗体（抗-HAV），而第一组除4人外、第二组除2人外均产生了抗乙型肝炎保护性抗体（抗-HBs）。在第7个月时，接种联合疫苗组的两种抗体几何平均滴度均增加了一倍以上：抗-HAV为3701 vs. 1705 mIU/ml，抗-HBs反应为1524 vs. 720 mIU/ml。注射部位疼痛是最常报告的局部症状，头痛是最常报告的全身症状。结论是，这种按两剂程序接种的甲乙肝联合疫苗耐受性良好且免疫原性高。
