Completed Infection & Immunity Lungs & Breathing

CCHF Vaccine manufacturing and First in Human Clinical Trial

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AI plain-English summary

A single-dose vaccine against Crimean-Congo haemorrhagic fever (CCHF) is now ready for its first human safety trial. CCHF is a tick-borne virus that kills 10 to 40 percent of infected people, with outbreaks occurring across Africa, the Balkans, the Middle East and parts of Asia. No vaccine currently exists for either humans or livestock. The virus spreads from ticks to livestock, mainly sheep, and then to humans through tick bites or contact with infected animal fluids, after which human-to-human transmission can occur. The Jenner Institute has already built a candidate vaccine using the same ChAdOx2 viral-vector platform that proved effective against Rift Valley fever in livestock and safe in multiple human vaccine programmes. In mice, a single dose provided complete protection. The next step is to manufacture a clinical-grade batch and test it in humans for the first time. If the trial succeeds, a safe, single-dose vaccine could prevent CCHF outbreaks in endemic regions, protect livestock, and reduce the risk of human-to-human spread during epidemics. This would fill a critical gap in global preparedness for a severe haemorrhagic fever with no current medical countermeasures.

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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.

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Related Research

Grants with similar aims, by meaning.

Preclinical Crimean Congo Haemorraghic Fever Vaccine Development
Development of a subunit vaccine against CCHF virus for use in low-middle income countries; completion of pre-clinical studies
Phase I Study of a MVA based vaccine for Crimean Congo Heamoraghic fever
A Peptide-mRNA Vaccine for Crimean-Congo Haemorrhagic Fever (CCHF)
Development of an economically viable CCHF virus vaccine

Original classification

Small Business Research Initiative

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