hVIVO, has signed a contract with the UK government to develop a COVID-19 (SARS-CoV-2) human challenge study model. The model development involves the manufacture of the challenge virus and the first-in-human characterisation study for this virus.
The contract starts immediately and could be worth approximately £10 million to hVIVO – a subsidiary of Open Orphan – depending upon the final number of volunteers that are included in the characterisation study.
The government has also secured the first three slots to test vaccines using hVIVO’s COVID-19 challenge study, which is expected to start in 2021. Each slot reservation has been secured at a cost of £2.5m bringing the total value of these slot reservations to £7.5m.
The characterisation study, which is expected to complete in May 2021 and will require regulatory and ethical approval, enables identification of the most appropriate dose of the challenge virus for use in future human challenge studies which play a vital role in helping to develop vaccines and antivirals for infectious diseases such as COVID-19.
The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics. hVIVO will also be expanding its Clinical Operations in London to facilitate work at this site.
hVIVO’s category 2 facility at Queen Mary’s Bioenterprise Centre, London, will continue to be used to deliver the company’s traditional challenge study contracts, particularly respiratory syncytial virus (RSV) and is booked to maximum capacity until Summer 2021.
hVIVO has a history of successfully delivering human challenge studies. The company, formerly called Retroscreen Virology, was originally established in 1989 as a spin out from Queen Mary University, London. Prior to this hVIVO’s founders worked at the common cold unit at Harvard Hospital, near Salisbury. The Salisbury Flu Clinic, as it is more commonly known, has a history of running human challenge studies since 1945. hVIVO has the world’s leading portfolio of eight human challenge study models developed to date and has safely run more human challenge studies than any other company globally. The expertise built up over this long history underpins hVIVO position as the market leader in the provision of human challenge studies.
Cathal Friel, Executive Chairman, Open Orphan, said: “At Open Orphan we are pleased to be working on behalf of the UK government and in partnership with two great institutions, Imperial College London and The Royal Free Hospital. We look forward to working with our partners to develop a COVID-19 human challenge study model which will be used to safely accelerate the discovery of effective vaccines and antivirals against COVID-19.
“We hope our work will reduce the impact of COVID-19 on individuals and communities, and our thoughts go out to the many people whose lives have been affected by the pandemic.”
Alok Sharma, Business Secretary, UK government, said: “We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine.
“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”
Image credit: Sam Moqadam