Nothdurft H D, Dietrich M, Zuckerman J N, Knobloch J, Kern P, Vollmar J, Sänger R
Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians-Universitaet Muenchen, Leopoldstrasse 5, 80802, Munich, Germany.
Vaccine. 2002 Jan 15;20(7-8):1157-62. doi: 10.1016/s0264-410x(01)00432-7.
Increasing travel stresses the requirement for rapid protection against infections such as hepatitis A and B.
This randomised, multicentre study investigated an accelerated vaccination schedule using a combined hepatitis A and B vaccine (Twinrix, Smithkline Beecham Biologicals) compared with simultaneous administration of the two corresponding monovalent vaccines. The combined vaccine was administered on days 0, 7 and 21, whereas the comparison group received hepatitis A vaccine on day 0 and hepatitis B vaccine on days 0, 7 and 21. All subjects received booster vaccination at month 12.
At month 1, 100% of subjects in the combined group and 99% of the controls were seropositive for anti-HAV antibodies. The corresponding seroprotection rates for anti-HBs antibodies were 82.0 and 83.9%, respectively. Examination of the 95% confidence intervals (CIs) for the treatment differences showed the two vaccines to be equivalent in terms of immunogenicity 1 week after the initial vaccination course. Just prior to the booster, the seropositivity rate for anti-HAV was 96.2% in the combined group and 95% in the control group. For anti-HBs, this was 94 and 91.6%, respectively. All subjects were seropositive for anti-HAV and seroprotected against hepatitis B at month 13. The anti-HAV GMCs were 9571mIU/ml with the combined vaccine and 5206mIU/ml in control subjects. The anti-HBs titre was 26002 and 29,196mIU/ml, respectively. Both groups had a similar reactogenicity profile.
The accelerated schedule of the combined vaccine provides a good immune response against hepatitis A and B antigens and is suitable for last minute immunisation.
旅行日益频繁,这就迫切需要针对甲型和乙型肝炎等感染迅速提供保护。
这项随机、多中心研究调查了一种加速接种方案,使用甲型和乙型肝炎联合疫苗(安在时,史克必成生物制品公司),并与同时接种两种相应单价疫苗进行比较。联合疫苗在第0、7和21天接种,而对照组在第0天接种甲型肝炎疫苗,在第0、7和21天接种乙型肝炎疫苗。所有受试者在第12个月时接受加强免疫。
在第1个月时,联合组100%的受试者和对照组99%的受试者抗甲型肝炎病毒抗体呈血清阳性。抗乙型肝炎病毒表面抗体的相应血清保护率分别为82.0%和83.9%。对治疗差异的95%置信区间(CI)进行检查表明,在初次接种疫苗疗程1周后,两种疫苗在免疫原性方面相当。就在加强免疫前,联合组抗甲型肝炎病毒血清阳性率为96.2%,对照组为95%。对于抗乙型肝炎病毒表面抗体,这一比例分别为94%和91.6%。在第13个月时,所有受试者抗甲型肝炎病毒呈血清阳性且对乙型肝炎具有血清保护作用。联合疫苗组抗甲型肝炎病毒几何平均浓度(GMC)为9571mIU/ml,对照组为5206mIU/ml。抗乙型肝炎病毒表面抗体滴度分别为26002和29196mIU/ml。两组的反应原性情况相似。
联合疫苗的加速接种方案对甲型和乙型肝炎抗原产生良好的免疫反应,适用于紧急免疫接种。