CCHF Vaccine manufacturing and First in Human Clinical Trial

Crimean Congo Haemorraghic Fever virus (CCHFv) is a severe haemorraghic tick-borne disease which causes outbreaks with a case fatality rate of 10-40%. Ticks infect livestock, mainly sheep, although many species may be infected, and humans may be infected by tick bites or contact with infected animal body fluids after which human to human transmission may occur. The disease is endemic in Africa, the Balkans, the Middle East and parts of Asia and no vaccine is available for either humans or livestock. The Jenner Institute has developed the replication-deficient simian adenoviral vector platform ChAdOx1and ChAdOx2 to produce vaccines against a number of outbreak pathogens. ChAdOx-vectored vaccines are highly immunogenic for both humoral and cell-mediated responses after a single dose, can be produced in a highly efficient manufacturing process and can be thermostabilised. Efficacy in livestock against Rift Valley Fever virus and safety in humans in a number of different vaccine programmes has been demonstrated. A ChAdOx2 CCHF vaccine has been produced and is completely protective in a mouse CCHF disease model after a single dose of the vaccine. We now propose to use established vaccine manufacturing technology to produce a cGMP batch of ChAdOx2 CCHF and conduct a First in Human clinical trial. These are the next steps required for clinical development and eventual licensure and use of a safe, effective, single dose vaccine against CCHF.