International Serological Standard for Plague

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.