International Serological Standard for Plague

虽然许多人认为鼠疫是一种只在历史书上发现的疾病，但全球每年有数千人感染由鼠疫耶尔森氏菌引起的感染。这种感染通常通过受感染跳蚤的叮咬传播给人，尽管在疫情爆发时，感染者呼出的飞沫会直接感染接受者的肺部。幸运的是，感染可以用抗生素有效地治疗。然而，在受影响最严重的国家：刚果、秘鲁和马达加斯加，获得医疗保健并不是一帆风顺的。此外，还有细菌获得抗生素耐药性的风险，这将使目前的治疗毫无价值。虽然疫苗已经开发出来，但世卫组织并不推荐它们，因此开发新的、更安全和更有效的疫苗是至关重要的。开发鼠疫等危险疾病疫苗的一个主要挑战是需要在高度生物遏制的实验室进行关键的实验研究。这是非常昂贵的，并阻碍了疫苗研发人员对这些疾病的研究。已知的是，从感染中恢复的恢复期患者的血液中有抗体，可以保护他们免受再次感染。疫苗需要安全地刺激这些抗体。然而，测量这些保护性抗体并不是一帆风顺的。我们需要的是一种协调这一衡量标准的方法。国家生物标准和控制研究所(隶属于英国药品和保健产品监管机构)在生产和供应协调传染病抗体测量的参考材料方面拥有45年的记录。其中许多参考物质已被世界卫生组织(WHO)确立为国际标准--测量抗体的主要测量“标尺”。在这个项目中，NIBSC将与位于波顿邓恩的国防科学技术实验室及其专业遏制实验室和马达加斯加巴斯德研究所合作开发鼠疫抗体参考标准。近年来，75%的鼠疫感染发生在马达加斯加巴斯德。实验数据将提交给世界卫生组织，从而获得国际标准的地位。我们的目标是在12个月内完成这项工作，考虑到实际挑战，这将是非常快的。这种材料的可获得性将支持像牛津疫苗集团这样的疫苗研发人员，他们拥有进入临床试验的候选鼠疫疫苗。如果这种疫苗和其他实验性疫苗通过监管机构的审查，那么鼠疫真的有可能成为一个历史故事。鉴于马达加斯加收集材料获得伦理批准的延长时间框架，该项目仍在进行中。

Whilst many people think of Plague as a disease only found in history books, each year globally several thousand people contract the infection which is caused by the bacterium _Yersinia pestis_. This infection is usually transmitted to people through a bite from an infected flea, although in outbreaks, droplets exhaled from infected people directly infect the lungs of recipients. Fortunately, infections may be treated effectively with antibiotics. However, in the countries worst affected: Congo, Peru and Madagascar, access to medical care is not straight forward. Moreover, there is the risk of the bacteria acquiring antibiotic resistance, which would make current treatment worthless. Whilst vaccines have been developed, they are not recommended by WHO, so the development of new, safer and more efficacious vaccines is essential.A major challenge in the development of vaccines for dangerous diseases like Plague is the need to perform key experimental studies in high bio-containment laboratories. This is very expensive and deters vaccine developers from working on these diseases. What is known is that convalescent patients who have recovered from infection have antibodies in their blood that protects them on re-exposure. Vaccines need to stimulate these antibodies safely. However measuring these protective antibodies is not straightforward. What is needed is a way of harmonising this measurement. The National Institute for Biological Standards and Control (part of the UK Medicines and Healthcare products Regulatory Agency) has a 45-year track record of producing and supplying reference materials that harmonise measurement of antibodies to infectious diseases. Many of these reference materials have been established by the World Health Organisation (WHO) as International Standards -- the primary measurement "yardstick" for measuring antibodies.In this project, NIBSC will collaborate with Defence Science Technology Laboratories at Porton Down, with their specialist containment laboratories and the Institute Pasteur, Madagascar, where 75% of plague infections have occurred in recent years, to develop an antibody reference standard for Plague. Experimental data will be submitted to the WHO so it can be accorded the status of International Standard. The goal is to have this done within 12 months, which would be remarkably fast considering the practical challenges.The availability of such a material will support vaccine developers like the Oxford Vaccine Group who have candidate plague vaccines entering clinical trials. If this and other experimental vaccines pass the scrutiny of regulators, then there really is a chance that Plague will become a story from history.Given the extended time frame to secure ethical approval for collection of materials in Madagascar the project is ongoing.