Gellin B G, Greenberg R N, Hart R H, Bertino J S, Stein D H, Deloria M A, Clements-Mann M L
Center for Immunization Research, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland 21205, USA.
J Infect Dis. 1997 Jun;175(6):1494-7. doi: 10.1086/516485.
To determine the immunogenicity of two doses of yeast recombinant hepatitis B virus (HBV) vaccine containing surface (S) protein, an open-label, multicenter trial was conducted in 199 healthy HBV-seronegative adults > or = 40 years old. Volunteers were randomly assigned to 1 of 5 groups to receive a total of three 10-microg doses, at 0, 1, and 6 months, or a total of two doses of 20 microg and 10 microg, 20 microg and 20 microg, 40 microg and 10 microg, or 40 microg and 20 microg at 0 and 6 months. The 40-microg/20-microg regimen elicited the highest rate of seroprotection (96.2%), with a geometric mean titer of antibody against the S protein of 369 mIU/mL, not significantly different from the 536 mIU/mL achieved with three doses. These results suggest that a two-dose regimen can achieve seroprotection similar to that of the three-dose regimen. Whether a shorter interval can be used or a booster dose will be needed later to confer durable immunity are unknown.
为确定两剂含表面（S）蛋白的酵母重组乙型肝炎病毒（HBV）疫苗的免疫原性，对199名年龄≥40岁的健康HBV血清学阴性成年人开展了一项开放标签、多中心试验。志愿者被随机分配到5组中的1组，在0、1和6个月时共接种3剂10μg疫苗，或在0和6个月时分别接种2剂，剂量组合为20μg和10μg、20μg和20μg、40μg和10μg或40μg和20μg。40μg/20μg方案引发的血清保护率最高（96.2%），抗S蛋白抗体的几何平均滴度为369 mIU/mL，与3剂方案所达到的536 mIU/mL无显著差异。这些结果表明，两剂方案可实现与三剂方案相似的血清保护。尚不清楚是否可以使用更短的间隔时间，或者以后是否需要加强剂量以提供持久免疫力。
