Van Herck K, Van Damme P, Collard F, Thoelen S
Centre for the Evaluation of Vaccination, WHO Collaborating Centre for Prevention and Control of Viral Hepatitis, Epidemiology and Community Medicine, University of Antwerp, Belgium.
Scand J Gastroenterol. 1999 Dec;34(12):1236-40. doi: 10.1080/003655299750024760.
In this open, randomized trial the safety, reactogenicity, and immunogenicity profile of a high-dose combined hepatitis A and B candidate vaccine was compared with that of Twinrix Paediatric in healthy volunteers aged 11-18 years.
One hundred subjects were randomly allocated to either of two groups. One group received the high-dose vaccine (720 E1.U HAV antigen; 20 microg hepatitis B surface antigen (HBsAg) at months 0 and 6; the second group received Twinrix Paediatric (360 E1.U HAV antigen; 10 microg HBsAg), following a 0-1-6-month schedule.
Injection site soreness and fatigue were the most frequently reported solicited symptoms. For hepatitis A all subjects had seroconverted at month 7, and geometric mean titres (GMT) were 8,151 mIU/ml in the high-dose group and 6,394 mIU/ml in the Twinrix Paediatric group. For hepatitis B the GMT for the Twinrix Paediatric group was significantly higher at month 2 and month 6. However, no difference in GMT between groups could be established at month 7. The seroprotection rate attained 100% in both groups, and GMT were 4,212 mIU/ml (high-dose group) and 6,330 mIU/ml (Twinrix Paediatric).
The two vaccines showed similar safety and reactogenicity profiles. After completion of the vaccination schedule, no difference in immunogenicity was shown. This high-dose vaccine, administered following a two-dose schedule, can be considered an alternative regimen for the immunization of healthy adolescents against hepatitis A and hepatitis B infections, in a setting where vaccinees are not immediately at risk of exposure to hepatitis B.
在这项开放性随机试验中，比较了高剂量甲型和乙型肝炎联合候选疫苗与儿童用双抗原重组乙肝疫苗（Twinrix Paediatric）在11至18岁健康志愿者中的安全性、反应原性和免疫原性。
100名受试者被随机分配到两组中的一组。一组在第0个月和第6个月接种高剂量疫苗（720 E1.U甲型肝炎抗原；20微克乙型肝炎表面抗原（HBsAg））；第二组按照0-1-6月的接种程序接种儿童用双抗原重组乙肝疫苗（360 E1.U甲型肝炎抗原；10微克HBsAg）。
注射部位疼痛和疲劳是最常报告的预期症状。对于甲型肝炎，所有受试者在第7个月时均血清阳转，高剂量组的几何平均滴度（GMT）为8151 mIU/ml，儿童用双抗原重组乙肝疫苗组为6394 mIU/ml。对于乙型肝炎，儿童用双抗原重组乙肝疫苗组在第2个月和第6个月时的GMT显著更高。然而，在第7个月时两组之间的GMT没有差异。两组的血清保护率均达到100%，GMT分别为4212 mIU/ml（高剂量组）和6330 mIU/ml（儿童用双抗原重组乙肝疫苗组）。
两种疫苗显示出相似的安全性和反应原性。完成接种程序后，未显示出免疫原性方面的差异。这种按照两剂程序接种的高剂量疫苗，在接种者没有立即接触乙型肝炎风险的情况下，可被视为健康青少年预防甲型和乙型肝炎感染的替代接种方案。
