Yanagisawa Naoki, Takayama Naohide, Suganuma Akihiko
Department of Infectious Diseases, Tokyo Metropolitan Komagome Hospital.
Kansenshogaku Zasshi. 2008 Sep;82(5):441-4. doi: 10.11150/kansenshogakuzasshi1970.82.441.
After severe exposure to suspected rabid animal, WHO recommends a complete vaccine series using a potent effective vaccine that meets WHO criteria, and administration of rabies immunoglobulin (RIG). RIG is not available globally, and is not marketed in Japan. If pre-exposure prophylaxis for rabies is given, RIG is unnecessary even after severe exposure. It is thus important to give pre-exposure prophylaxis for rabies to people who plan to go to rabies-endemic areas. In Japan, pre-exposure prophylaxis for rabies consists of 3 doses of cell-culture rabies vaccine. The first two doses are given 4 weeks apart, and the third dose is given 6-12 months after the first dose, all of which are injected subcutaneously (standard regimen). People who plan to travel abroad to rabies-endemic areas may know of their destinations only 1 or 2 months in advance at best. Therefore, it is virtually impossible to complete the 3 dose regimen for rabies in Japan. Pre-exposure prophylaxis recommended by WHO consists of 3 doses given intramuscularly on days 0, 7, and 28, making it possible to complete pre-exposure prophylaxis in one month. This WHO recommended pre-exposure prophylaxis using Japanese cell-cultured rabies vaccine (PCEC-K) has not been studied, so we elected to fill the gap using PCEC-K, administered based on the WHO recommendation and examined its efficacy and safety. Subjects were 26 healthy volunteers with no previous rabies vaccination giving oral and written consent. Vaccine was administered on days 0, 7, and 28, and rabies antibody levels were tested on days 7, 28, and 42. On day 7, every antibody level was negative. On day 28, antibody levels were between 0.7-3.5 EU/ mL, with the exception of 3 cases still negative. On day 42, all cases, including the 3 negative cases, exceeded 1.6 EU/mL, providing sufficient protection against rabies. This result was not inferior compared to the standard regimen. Local adverse effects such as erythema and pain were noted, but none were serious. In conclusion, WHO recommended pre-exposure prophylaxis for rabies using PCEC-K is considered effective and safe.
在严重暴露于疑似患有狂犬病的动物后，世界卫生组织（WHO）建议使用符合其标准的高效疫苗进行完整的疫苗接种系列，并注射狂犬病免疫球蛋白（RIG）。RIG在全球并非都有供应，在日本也未上市。如果进行了狂犬病暴露前预防，即使在严重暴露后也无需使用RIG。因此，对于计划前往狂犬病流行地区的人群，进行狂犬病暴露前预防非常重要。在日本，狂犬病暴露前预防包括3剂细胞培养狂犬病疫苗。前两剂间隔4周接种，第三剂在第一剂接种后6至12个月接种，均采用皮下注射（标准方案）。计划前往国外狂犬病流行地区旅行的人，最多只能提前1或2个月知晓目的地。因此，在日本几乎不可能完成狂犬病3剂接种方案。WHO推荐的暴露前预防方案是在第0、7和28天进行3剂肌肉注射，这样有可能在1个月内完成暴露前预防。WHO推荐的使用日本细胞培养狂犬病疫苗（PCEC-K）进行暴露前预防尚未得到研究，因此我们选择按照WHO的建议使用PCEC-K来填补这一空白，并对其有效性和安全性进行了研究。研究对象为26名未曾接种过狂犬病疫苗且签署了口头和书面同意书的健康志愿者。在第0、7和28天接种疫苗，并在第7、28和42天检测狂犬病抗体水平。在第7天，所有抗体水平均为阴性。在第28天，除3例仍为阴性外，抗体水平在0.7 - 3.5 EU/mL之间。在第42天，包括3例阴性病例在内的所有病例抗体水平均超过1.6 EU/mL，提供了足够的狂犬病防护。这一结果与标准方案相比并不逊色。观察到了如红斑和疼痛等局部不良反应，但均不严重。总之，WHO推荐的使用PCEC-K进行狂犬病暴露前预防被认为是有效且安全的。
