cchfv vaccine for lmics - transition from preclinical to clinical studies

Crimean Congo Haemorrhagic Fever virus (CCHFv) is endemic in \>30 countries, almost all Low Middle Income Countries (LMICs) in Africa, the Balkans, Middle East and Asia with an estimated 3 billion people at risk. The expanding geographic range of the tick host along with trade in infected but asymptomatic livestock is fuelling the spread of CCHFv. Virus outbreaks often occur in agricultural areas in workers with close contact with animals, spreading to family members and health workers. Thus CCHFv, along with some of the world's other deadliest diseases, affects areas least able to deal with them or afford vaccine development. There is no vaccine, nor effective treatment or standardised diagnostic assay; early intensive care, rehydration and supportive drug therapy are the main care pathways. There are 10-15,000 cases annually; 1 in 8 develop severe disease with mortality rates between 10 and 40% (WHO). Survivors typically experience long term debilitating symptoms that have additional socio-economic impacts. CCHFv is sixth on the WHO list of viruses with pandemic potential for which no vaccine or therapy exists. The disease is already a major health concern in Turkey with isolated cases spreading northwards into Southern Europe, which is being made worse by the increasing geographical spread of the tick vector caused by climate change. Our project aims to develop an affordable and effective vaccine for CCHFv using our platform technologies for producing high quality proteins, including viral glycoproteins, in insect cells. This project will build on the results and achievements of our current UK Vaccine Network project and ensure we are well prepared and ready to move to Phase I/II Clinical Trials in future. In this two year project, we will finalise the conditions for manufacture of Gc and Gn at scale and transfer the technology to a GMP manufacturing facility for production of material for stability and toxicology studies. We will also beta test a CCHFv diagnostic assay with partners from LMIC countries including Turkey, Bulgaria, Kazakhstan and Tajikistan. A standardised CCHF assay is urgently needed in LMICs and will be needed by us to screen participants for a future Phase II Clinical Trial. We will also create a regulatory package and develop a detailed plan to undertake Phase I/Phase II Trials to allow future Clinical work to start as soon as funding is available.