Theilmann L, Kallinowski B, Gmelin K, Hofmann F, Scheiermann N, Wohland B, Stickl H, Maiwald H, Moriabadi F K, Bock H L
Medizinische Universitätsklink, Heidelberg, Germany.
Vaccine. 1992;10 Suppl 1:S132-4. doi: 10.1016/0264-410x(92)90567-4.
To study the immunogenicity and reactogenicity of an inactivated hepatitis A vaccine, 204 healthy individuals were randomized into three equal groups, each to receive a different vaccine lot. Each subject received a total of three doses, each of 720 ELISA units of hepatitis A vaccine HM175, according to a 0 and 1 month primary vaccination schedule, with a booster dose given at month 6. Side effects were low and were < 30% after the second injection. All subjects but one had antibodies to hepatitis A virus two months after the first dose of vaccine. At month 6 all vaccinees had seroconverted. There were no differences between the three vaccine lots with respect to side effects, seroconversion rates and geometric mean titre of antibodies. We conclude that the three lots of inactivated hepatitis A vaccine are safe, well tolerated and equally immunogenic.
为研究一种甲型肝炎灭活疫苗的免疫原性和反应原性，将204名健康个体随机分为三组，每组接受不同批次的疫苗。根据0月和1月的基础免疫接种程序，每名受试者共接种三剂，每剂含720 ELISA单位的甲型肝炎疫苗HM175，并在第6个月给予加强剂量。副作用发生率较低，第二次注射后副作用发生率<30%。除一名受试者外，所有受试者在接种第一剂疫苗两个月后均产生了甲型肝炎病毒抗体。在第6个月时，所有接种者均发生了血清转化。在副作用、血清转化率和抗体几何平均滴度方面，三个疫苗批次之间没有差异。我们得出结论，这三个批次的甲型肝炎灭活疫苗安全、耐受性良好且免疫原性相同。
