Serological Vaccine Standards for Emerging Diseases

The development of safe, effective and economically affordable vaccines against Emerging Diseases, such as Ebola and Zika, would provide powerful tools not only to prevent re-emergence of these diseases in countries where they are endemic, but also enable swift and effective control of outbreaks initiated by infected returning travellers. However, these infectious agents can only be handled under high levels of bio-security, making the cost of research on these agents prohibitive for most commercial organisations. The availability of established standards and reference materials accelerates the development of licenced vaccines. Where there is robust evidence that convalescent serum (ie serum obtained from someone who has recovered from an infectious disease) protects against reinfection, then the preparation and distribution of serum standards that have been demonstrated to confer protection against infection is hugely beneficial. These serum standards facilitate pre-clinical and early clinical development and selection of the most promising experimental vaccine without the need for expensive studies under bio-containment, as the serum standard provides as in vitro reference marker for serological protection. NIBSC is the global leader in the development of World Health Organisation (WHO) established International Standards and reference materials for biological medicines such as vaccines. At the request of the WHO, NIBSC is undertaking a programme to develop and establish sero-diagnostic reference materials for the WHO's List of Priority Pathogens,that heavily overlaps with the UK Vaccine Network Priority Emerging Diseases. NIBSC has prepared an International Standard for anti-Ebola virus antibodies that was established by the WHO's Expert Committee for Biological Standardisation in October 2017. An anti-Zika virus antibody standard will be reviewed in October 2018 as well as a preliminary report about an anti-MERS-CoV antibody material. Whilst these candidate materials have been through detailed in vitro analyses in international collaborative studies, without additional competitively awarded funding from InnovateUK, it would not have been possible to establish that the serological reference materials contained specific antibodies capable of preventing infection or disease in in vivo model systems. They are now established as serological vaccine standards and available globally. This previous Innovate UK funding, (for 1 year) enabled NIBSC to collaborate with Dstl and PHE laboratories at Porton Down. Their high level bio-containment facilities allowed these critical protection studies to be performed and demonstrated that serological reference materials against Ebola, Zika and MersCoV could protect against these lethal diseases. Having established an effective collaboration between the 3 centres, NIBSC is now seeking a further 2 years funding to build on this momentum, utilising this PLATFORM TECHNOLOGY to prepare a further 9 candidate sero-diagnostic reference preparations, one each for the remaining UK Vaccine Network Priority Emerging Diseases, and establish whether these materials can protect in appropriate in vivo model systems. If materials protect, then they add to the list of serological vaccine standards and thus accelerate vaccine development against Chikungunya, CCHF, Marburg, Lassa Fever, Nipah, Hanta, Rift Valley Fever viruses and bacterial infections Q Fever and Plague.