两剂次10微克和20微克乙型肝炎疫苗的免疫原性

Immunogenicity of 10 and 20 microgram hepatitis B vaccine in a two-dose schedule.

作者信息

ul-Haq Najib, Hasnain Syed S, Umar Muhammad, Abbas Zaigham, Valenzuela-Silva Carmen, Lopez-Saura Pedro

机构信息

Khyber Medical College, Pakistan R-4, University Campus, North West Frontier Province, Peshawar, Pakistan.

出版信息

Vaccine. 2003 Jul 4;21(23):3179-85. doi: 10.1016/s0264-410x(03)00232-9.

DOI:10.1016/s0264-410x(03)00232-9

PMID:12804846

Abstract

Healthy subjects (15-50 years old) were randomised to receive, intramuscularly, 10 or 20 micrograms of a yeast-derived recombinant hepatitis B vaccine (Heberbiovac HB) on a two-dose (0-1) schedule. Anti-hepatitis B surface antigen antibodies (HBsAb) were determined at 2, 3 and 6 months. Twenty micrograms immunisation yielded 96.3% seroprotection (HBsAb >10 IU/l) at t=3, which persisted to 97.2% at t=6. The 10 microgram group resulted in 87.4% seroprotection at t=3 and 81% at t=6, but reached >95% among subjects <21 years old, both at t=3 and 6. It is concluded that the vaccine used is highly immunogenic and the two-dose 20 microgram immunisation can be used in all age groups and 10 micrograms in subjects up to 20 years. These schedules can result in significantly better compliance and cost-effectiveness of the vaccination programs.

摘要

健康受试者（15至50岁）被随机分组，按照0月和1月两剂次的接种程序，通过肌肉注射分别接种10微克或20微克酵母重组乙型肝炎疫苗（Heberbiovac HB）。在第2、3和6个月时检测抗乙型肝炎表面抗原抗体（HBsAb）。20微克剂量组在第3个月时的血清保护率（HBsAb>10 IU/l）为96.3%，至第6个月时持续为97.2%。10微克剂量组在第3个月时的血清保护率为87.4%，第6个月时为81%，但在21岁以下受试者中，第3个月和第6个月时均达到95%以上。结论是所使用的疫苗具有高度免疫原性，20微克两剂次接种程序可用于所有年龄组，10微克接种程序可用于20岁及以下人群。这些接种程序可显著提高疫苗接种计划的依从性和成本效益。