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Rabipur 狂犬病疫苗接种 30 年:临床数据和全球经验总结。

30 Years of rabies vaccination with Rabipur: a summary of clinical data and global experience.

机构信息

Novartis Vaccines and Diagnostics GmbH, Global Medical Affairs, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany.

出版信息

Expert Rev Vaccines. 2015 Mar;14(3):351-67. doi: 10.1586/14760584.2015.1011134.

DOI:10.1586/14760584.2015.1011134
PMID:25683583
Abstract

Rabies poses a threat to more than 3.3 billion people worldwide and is estimated to cause about 60,000 deaths a year. However, according to the WHO, it is still one of the most neglected diseases in developing countries. Human rabies vaccinations are critical components of pre-exposure and post-exposure prophylaxis. Rabipur [corrected], the first purified chick embryo cell-culture vaccine, was licensed in Germany in 1984, and later in more than 60 countries worldwide [corrected].The immunogenicity, efficacy and safety of Rabipur have been assessed in numerous clinical trials in pre- and post-exposure regimens, using both intramuscular and intradermal routes of administration. The trial populations have involved adults and children, including healthy volunteers and individuals bitten by laboratory-proven rabid animals, malnourished children and immunocompromised individuals. Extensive, worldwide clinical experience with Rabipur over the past 30 years has shown the vaccine to be immunogenic, effective and generally well tolerated.

摘要

狂犬病对全球超过 33 亿人构成威胁,据估计每年导致约 6 万人死亡。然而,根据世界卫生组织的说法,它仍然是发展中国家最被忽视的疾病之一。狂犬病暴露前和暴露后预防的关键组成部分是人用狂犬病疫苗。Rabipur[已更正]是首个纯化鸡胚细胞培养疫苗,于 1984 年在德国获得许可,随后在全球 60 多个国家获得许可[已更正]。Rabipur 的免疫原性、疗效和安全性已在许多临床研究中进行了评估,包括肌肉内和皮内途径给药的暴露前和暴露后方案。试验人群包括成年人和儿童,包括健康志愿者和被实验室确诊患有狂犬病的动物咬伤的个体、营养不良的儿童和免疫功能低下的个体。过去 30 年来,Rabipur 在全球范围内的广泛临床经验表明,该疫苗具有免疫原性、有效性和良好的耐受性。

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