Toffler W L, Olenick J S, Wolf N E, Retzlaff Z H, Swanson J R, Kenny T A
Department of Family Medicine, Oregon Health Sciences University, Portland 97201.
J Fam Pract. 1991 Aug;33(2):149-54.
One of the chief barriers to a greater use of hepatitis B vaccine is the high cost of the vaccine itself. A number of small research trials have shown that an adequate immune response can be induced at a much lower cost by administering one tenth of the vaccine using an intradermal technique. The purpose of this study was to ascertain whether these results could be replicated in a larger clinical trial.
Vaccine recipients included health care providers, police officers, and firefighters. Recipients were given 0.1 mL of plasma-derived hepatitis B vaccine intradermally on days 1, 30, and 180. Antibody response was measured on day 210, with seroconversion defined as a sample-to-negative (S/N) ratio of greater than or equal to 10. Any local and systemic side effects were documented.
Six hundred sixteen individuals completed the vaccination series, and seroconversion occurred in 534 (86.7%). The rate of seroconversion in those younger than 40 years was 91.2% and in those 40 years and older was 75.1%. The mean S/N ratio was 154.9 (range 0 to 620) and decreased with increasing age (r = -.25, P = .0001). Side effects were largely limited to local reactions.
The results support the use of the intradermal technique as a cost-effective alternative to the intramuscular route in individuals younger than 40 years. The intradermal technique may be used in older individuals if titers are obtained to assure seroconversion. Because of the restricted availability of the plasma-derived vaccine used in this study, similar trials with recombinant vaccine should be undertaken.
更广泛使用乙型肝炎疫苗的主要障碍之一是疫苗本身成本高昂。多项小型研究试验表明，采用皮内注射技术接种十分之一剂量的疫苗，就能以低得多的成本诱导出足够的免疫反应。本研究的目的是确定这些结果能否在更大规模的临床试验中得到重复。
疫苗接种对象包括医护人员、警察和消防员。在第1天、第30天和第180天给接种对象皮内注射0.1毫升血浆源性乙型肝炎疫苗。在第210天测量抗体反应，血清转化定义为样本与阴性对照（S/N）比值大于或等于10。记录所有局部和全身副作用。
616人完成了疫苗接种系列，534人（86.7%）发生了血清转化。40岁以下人群的血清转化率为91.2%，40岁及以上人群的血清转化率为75.1%。平均S/N比值为154.9（范围0至620），且随年龄增长而降低（r = -0.25，P = 0.0001）。副作用主要局限于局部反应。
研究结果支持在40岁以下人群中，皮内注射技术可作为肌肉注射途径的一种经济有效的替代方法。如果检测滴度以确保血清转化，皮内注射技术也可用于年龄较大的个体。由于本研究中使用的血浆源性疫苗供应有限，应开展使用重组疫苗的类似试验。
