狂犬病疫苗制剂效价评价综述

walaa Rashed, Khaled Aboshanab, M. Aboulwafa
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摘要

狂犬病仍然被认为是温血动物中最有害的病毒感染之一。全世界每年有成千上万的人感染这种疾病。除非在症状出现之前及早治疗,否则这是一种致命的疾病。病毒通常通过患狂犬病动物唾液的咬伤进入人体;然而,它也可以通过其他方式传播,例如与实验室工作人员一起吸入雾化的狂犬病毒。在非洲,每年大约有2.4万人死于狂犬病,而狗是感染传播的主要原因。幸运的是,它很容易被疫苗消灭。疫苗接种的重要性在于,它是限制疾病死亡率水平的唯一途径;同时,同样的疫苗用于狂犬病感染暴露后的治疗或预防。因此,必须对其进行高质量的控制,以确保其安全性、有效性和效力。效价试验是检验已生产疫苗批次实际相对效价的重要工具。由于生物制品的高度可变性,效力是确保商业疫苗批次一致性的有效工具。本文就狂犬病病毒及其抗原结构、不同的疫苗制剂、疫苗的质量控制以及狂犬病疫苗制剂效价检测的不同方法(包括体内法和体外法)进行了综述。总之,如果没有良好的质量控制,我们就无法保证疫苗生产的一致性;如果没有对依赖动物的旧方法的替代,我们就无法在质量控制试验特别是效价试验中采用改良、减少和替代动物的全球方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Mini review on Potency Evaluation of Rabies Vaccine preparations
Rabies is still considered one of the most harmful viral infections of warm-blooded animals. Thousands of people are infected with it each year worldwide. It is a fatal disease unless early treatment is received before the appearance of symptoms. The virus usually enters the human body through a bite wound from rabid animal’s saliva; however, it can also be transmitted by other ways such as inhalation of the aerosolized rabies virus with laboratory workers. About, twenty-four thousand die due to rabies in Africa annually and dogs are the main reason for infection transmission. Fortunately, it is easily eliminated by vaccines. The importance of vaccination comes from the fact that it is the only way to limit disease mortality levels; meanwhile, the same vaccine is used for treatment after infection exposure to rabies or as prophylaxis. Therefore, high-quality control must be applied to it to ensure its safety, efficacy, and potency. A potency test is an important tool for experiencing the actual relative potency of manufactured vaccine batches. Because of the high variability of biological products, potency is an effective tool that assures the lot-to-lot consistency of commercial vaccines. In this review, we aimed to discuss the rabies virus and its antigenic structure, different vaccine preparations, quality control of vaccines, different methods used in potency tests for rabies vaccine preparations including in vivo and in vitro methods. In conclusion, without good quality control, we couldn’t ensure consistency in vaccine manufacturing, and without replacement of old methods depending on animals, we couldn’t go with global approaches of refinement, reduction, and replacement of animals in quality control tests especially the potency test.
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