Redfield R R, Innis B L, Scott R M, Cannon H G, Bancroft W H
JAMA. 1985 Dec 13;254(22):3203-6.
High cost and limited availability of the current hepatitis B virus vaccine lead to underutilization. To address this problem, we performed a vaccine trial comparing the currently recommended regimen of 20 micrograms of hepatitis B surface antigen (HBsAg) intramuscularly on days 0, 30, and 180, with a more economical regimen of 2 micrograms of HBsAg intradermally on days 0, 30, and 180. This trial was performed in 50 seronegative health care workers to assess the immunogenicity and local reactogenicity of both vaccine regimens. We found no significant difference in seroconversion between the intradermal group (96%) and the intramuscular group (100%). Mean ratios of test sample value to mean negative control value for antibody to HBsAg at 360 days were not significantly different (intradermal group, 84 +/- 26; intramuscular group, 120 +/- 22). Reactions in both groups were minor. Although the optimal dose of HBsAg was not investigated, our data demonstrate that 0.1 mL of inactivated hepatitis B virus vaccine (Heptavax-B) intradermally is immunogenic in healthy adults. Vaccination by this regimen can broaden hepatitis B virus disease prevention.
当前乙肝疫苗成本高昂且供应有限，导致其使用率低下。为解决这一问题，我们开展了一项疫苗试验，比较了目前推荐的方案（即分别于第0、30和180天肌肉注射20微克乙肝表面抗原[HBsAg]）与一种更经济的方案（即分别于第0、30和180天皮内注射2微克HBsAg）。该试验在50名血清阴性的医护人员中进行，以评估两种疫苗方案的免疫原性和局部反应原性。我们发现皮内注射组（96%）和肌肉注射组（100%）的血清转化率无显著差异。在第360天时，针对HBsAg抗体的检测样本值与平均阴性对照值的平均比值也无显著差异（皮内注射组，84±26；肌肉注射组，120±22）。两组的反应均较轻微。虽然未对HBsAg的最佳剂量进行研究，但我们的数据表明，0.1毫升灭活乙肝病毒疫苗（Heptavax - B）皮内注射对健康成年人具有免疫原性。采用该方案进行疫苗接种可扩大乙肝病毒疾病的预防范围。
