Poovorawan Y, Theamboonlers A, Safary A
Chulalongkorn University, Bangkok, Thailand.
Vaccine. 1996 Aug;14(12):1092-4. doi: 10.1016/0264-410x(96)00053-9.
The effect of two dose levels of inactivated hepatitis A vaccine was investigated for immunogenicity and reactogenicity in an open study in adolescents. The subjects were randomized into two groups and to receive a priming dose of 720 EL. U or 1440 EL. U of hepatitis A antigen, respectively. A booster of the same dose level was given at month 6. In group 1, receiving 720 EL. U, the seroconversion rates at 15 days and 1 month were 92% and 99%. The corresponding rates for group 2, receiving 1440 EL. U, were 98% and 100%. Higher geometric mean titres of antibody to hepatitis A virus were noted at 1, 6 and 7 months in the group receiving 1440 EL. U. The vaccine was well tolerated in both groups. The most frequent side effect was transient soreness at the site of inoculation. No serious adverse reactions were observed. The study demonstrated that inactivated hepatitis A vaccine is safe and immunogenic at a dose level of 720 EL. U or 1440 EL. U in adolescents.
在一项针对青少年的开放性研究中，研究了两种剂量水平的甲型肝炎灭活疫苗的免疫原性和反应原性。受试者被随机分为两组，分别接受720 EL.U或1440 EL.U甲型肝炎抗原的首剂接种。在第6个月给予相同剂量水平的加强针。在接受720 EL.U的第1组中，15天和1个月时的血清转化率分别为92%和99%。接受1440 EL.U的第2组的相应比率分别为98%和100%。在接受1440 EL.U的组中，在1、6和7个月时观察到甲型肝炎病毒抗体的几何平均滴度更高。两组对疫苗的耐受性均良好。最常见的副作用是接种部位的短暂疼痛。未观察到严重不良反应。该研究表明，720 EL.U或1440 EL.U剂量水平的甲型肝炎灭活疫苗在青少年中是安全且具有免疫原性的。
