Completed Infection & Immunity Public Health & Healthcare

CCHFv vaccine for LMICs - transition from preclinical to clinical studies

In plain English

AI plain-English summary

A tick-borne virus that kills up to 40% of those infected is spreading north into Europe as the climate warms, and there is no vaccine to stop it. Crimean-Congo haemorrhagic fever virus (CCHFv) already sickens people across more than 30 countries, mostly in Africa, the Middle East, Asia and the Balkans. Outbreaks hit agricultural workers, then spread to families and health workers. Survivors often face long-term debilitating symptoms. The World Health Organization ranks CCHFv sixth on its list of viruses with pandemic potential that lack a vaccine or treatment. No effective therapy or standardised diagnostic test exists either. This project aims to change that by developing an affordable vaccine. The team will finalise how to manufacture key viral proteins at scale, then transfer production to a facility that can make material for safety and stability testing. They will also beta-test a standardised diagnostic assay with partners in affected countries, which is urgently needed to screen participants for future clinical trials. A regulatory package and detailed plan for Phase I and Phase II trials will be prepared, so that clinical work can begin as soon as funding is secured. If successful, the vaccine could protect billions of people at risk and prevent the virus from becoming a global health crisis.

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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.

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Related Research

Grants with similar aims, by meaning.

Development of a subunit vaccine against CCHF virus for use in low-middle income countries; completion of pre-clinical studies
Development of an economically viable CCHF virus vaccine
Development of immune assays for CCHF to aid Phase I clinical trials
Crimean-Congo Haemorrhagic Fever Vaccine
Development of an economically viable CCHF virus vaccine for local production

Original classification

Small Business Research Initiative

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