Jilg W, Bittner R, Schätzl H, Rasshofer R, Schmidt M, Deinhardt F
Max von Pettenkofer Institute for Hygiene and Medical Microbiology, University of Munich, FRG.
J Hepatol. 1993;18 Suppl 2:S38-40. doi: 10.1016/s0168-8278(05)80376-9.
The immunogenicity and reactogenicity of different doses of hepatitis A vaccine was studied in healthy adult volunteers. Vaccinees (105) were immunized with 6.25, 12.5 or 25 ng of HAV antigen, each dose administered at 0, 1 and 6 months (groups B, C and D); one group (group A) obtained three 6.25 ng doses at 0, 1 and 2 months. After one single dose high seroconversion rates ranging between 63 and 85% were observed in all four groups. All participants had seroconverted after the third dose, irrespective of the antigen content per dose and the vaccination schedule. Geometric mean titers after three doses were 439 IU/l (group A, month 3) and 1492, 963 and 2772 IU/l in groups B, C and D at month 7. One year after the first injection all vaccinees tested still showed antibody levels well above 10 IU/l. The vaccine was very well tolerated. Minor localized symptoms were observed mainly such as slight pain at the injection site. These symptoms were not dose related; no serious side effects occurred.
在健康成年志愿者中研究了不同剂量甲型肝炎疫苗的免疫原性和反应原性。105名接种者分别用6.25、12.5或25纳克的甲型肝炎病毒(HAV)抗原进行免疫,每剂分别在0、1和6个月接种(B、C和D组);一组(A组)在0、1和2个月接种三剂6.25纳克。在所有四组中,单次接种后观察到高血清转化率,范围在63%至85%之间。所有参与者在第三剂接种后均发生血清转化,无论每剂抗原含量和接种方案如何。三组接种后第3个月时,A组的几何平均滴度为439 IU/l;第7个月时,B、C和D组的几何平均滴度分别为1492、963和2772 IU/l。首次注射一年后,所有检测的接种者抗体水平仍远高于10 IU/l。该疫苗耐受性良好。主要观察到轻微的局部症状,如注射部位轻微疼痛。这些症状与剂量无关;未发生严重副作用。