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[日本狂犬病疫苗皮内接种方案用于暴露前预防的效果]

[Efficacy of intradermal regimen using Japanese rabies vaccine for pre-exposure prophylaxis].

作者信息

Shiota Seiji, Ahmed Kamruddin, Mifune Kumato, Nishizono Akira

机构信息

Department of Microbiology, Faculty of Medicine, Oita University.

出版信息

Kansenshogaku Zasshi. 2010 Jan;84(1):9-13. doi: 10.11150/kansenshogakuzasshi.84.9.

DOI:10.11150/kansenshogakuzasshi.84.9
PMID:20170007
Abstract

In Japan, only one vaccine is commercially available for rabies (Chemo-Sero-Therapeutic Institute (Kaketsuken), Kumamoto, Japan). It is a tissue-cultured inactivated vaccine made using purified chick embryo cells (PCEC-K) and administered subcutaneously using a schedule differing from that recommended by the World Health Organization (WHO). The current regimen of pre-exposure prophylaxis for rabies in Japan consists of three subcutaneous administrations of PCEC-K vaccine at 0, 28, and 180 days, requiring 6 months to complete. With the exception of a few imported cases, Japan is rabies-free and rabies vaccine production is small. Globalization should trigger rabies re-emergence in Japan, however, we would have to determine whether PCEC-K vaccine is effective through intradermal administration following the WHO-recommended regimen. In a study of 50 healthy volunteers without a history of rabies vaccination and all of whom provided, PCEC-K vaccine (0.1 mL, 2 sites) was administered intradermal by on days 0, 7, and 28, and the viral neutralizing antibody level (VNA) against rabies virus was tested using the rapid fluorescent focus-inhibiting test (RFFIT) on days 0, 14, 28, 42, 56, 84, and 208. On day 42, all individuals showed adequate VNA (GMT: 3.21 IU /mL), maintained for 84 days. VNA acquisition differed slightly with the PCEC-K vaccine lot and local adverse effects were minor. The intradermal PCEC-K regimen was found to be safe and effective in inducing adequate VNA using a smaller amount of vaccine within a shorter period.

摘要

在日本,狂犬病只有一种市售疫苗(日本熊本县化学血清疗法研究所(Kaketsuken)生产)。它是一种使用纯化鸡胚细胞制成的组织培养灭活疫苗(PCEC-K),皮下注射的接种程序与世界卫生组织(WHO)推荐的不同。日本目前的狂犬病暴露前预防方案包括在0、28和180天皮下注射三次PCEC-K疫苗,需要6个月完成。除了少数输入性病例外,日本没有狂犬病,狂犬病疫苗产量也很少。然而,全球化可能会导致狂犬病在日本重新出现,我们必须确定按照WHO推荐的程序进行皮内注射时,PCEC-K疫苗是否有效。在一项针对50名无狂犬病疫苗接种史且均提供了知情同意的健康志愿者的研究中,于第0、7和28天皮内注射PCEC-K疫苗(0.1 mL,2个部位),并在第0、14、28、42、56、84和208天使用快速荧光灶抑制试验(RFFIT)检测针对狂犬病病毒的病毒中和抗体水平(VNA)。在第42天,所有个体均显示出足够的VNA(几何平均滴度:3.21 IU/mL),并维持了84天。不同批次的PCEC-K疫苗在VNA获得方面略有差异,局部不良反应轻微。研究发现,皮内注射PCEC-K方案安全有效,可在更短时间内使用较少量疫苗诱导产生足够的VNA。

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