UK Launches 1st Human Challenge Study for COVID-19 Vaccines
UK based Open Orphan plc (ORPH) announced the signing of a contract by hVIVO, a subsidiary, 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 characterization study for the SARS-CoV-2 virus.
In this initial phase, called the Virus Characterisation Study, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19.
The Human Challenge Programme, part of the government’s Vaccine Taskforce, is a partnership between the government, the NHS, academia, and the private sector to establish human challenge studies for COVID-19 in the UK.
Announced on October 20, 2020, the contract starts immediately. In addition, the UK Government has secured the first (3) slots to test vaccines using hVIVO's COVID-19 challenge study, which we expect to start in 2021.
The characterization study, which is expected to be completed in May 2021 and will require regulatory and ethical approval, enables the 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 stated in the press release ‘it has a long 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 8 human challenge study models developed to date and has safely run more human challenge studies than any other company globally.
Normally, challenge studies only happen when effective treatments for the disease are available, which makes infecting healthy people with COVID-19 ethically complex.
The safety of volunteers in any clinical study is always paramount; the partnership developing the human challenge model is working closely with the UK’s regulatory and ethics bodies to provide assurance that it is following established guidelines associated with clinical studies and that the design of the study minimizes the risk of harm.
The human challenge study will be reviewed by a specially convened ethics committee before any volunteers are enrolled and the Medicines and Healthcare products Regulatory Agency, an exemplar globally of medicines and device regulation, will approve the study before it is conducted.
Participants in the initial study will be carefully selected to exclude anyone with a characteristic that has been shown to increase the severity of COVID-19 infection.
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