Lu M Y, Chang M H, Tsai K S, Chen D S
Department of Pediatrics, National Taiwan University Hospital, Taipei.
Vaccine. 1999 Jan;17(1):26-30. doi: 10.1016/s0264-410x(98)00149-2.
Inactivated hepatitis A virus (HAV) vaccine was administered to 55 healthy seronegative adult volunteers to evaluate the immunogenicity and adverse reactions of two doses of HAV vaccination (25 units) in comparison with a three-dose regimen. The volunteers were randomly assigned to receive one of the two regimens: 26 were vaccinated with two doses at 0 and 24 weeks (Group 1), and 29 were vaccinated with three doses at 0, 2, and 24 weeks (Group 2). The vaccine was well tolerated and there was no serious adverse reaction. In both groups, the seroconversion rate was 100% at week 28. At week 52, all remained positive for anti-HAV regardless of a two- or three-dose regimen. No statistically significant difference in seroconversion rates and geometric mean titers could be demonstrated between the two groups. Thus, the two-dose regimen may be favorable to save cost and time for active immunization against hepatitis A.
对55名健康的血清阴性成年志愿者接种甲型肝炎病毒(HAV)灭活疫苗,以评估两剂次HAV疫苗(25单位)与三剂次方案相比的免疫原性和不良反应。志愿者被随机分配接受两种方案之一:26人在0周和24周接种两剂(第1组),29人在0周、2周和24周接种三剂(第2组)。疫苗耐受性良好,未出现严重不良反应。两组在第28周时血清转化率均为100%。在第52周时,无论采用两剂次还是三剂次方案,所有受试者的抗-HAV均保持阳性。两组之间的血清转化率和几何平均滴度无统计学显著差异。因此,两剂次方案可能有利于节省甲型肝炎主动免疫的成本和时间。