The UK government has commenced its first human challenge studies targeting COVID-19. Much like as occurred in places like China and Russia, healthy volunteers are deliberately infected with SARS-CoV-2 in a highly controlled and regulated environment. Sponsored by Imperial College London, the study will occur at the Royal Free Hospital in London, a Biosafety Level 3 ward. Up to 19 volunteers will participate in the human challenge study run by hVIVO, a research operation specializing in conducting human challenge studies.
Generally, thus far, clinical trial sponsors have avoided human challenge studies. Could this UK study represent the beginning of many more?
Alok Sharma, UK’s Business Secretary, has been active in several COVID-19 related drug development deals. Recently quoted in the hVIVO press release, Mr. Sharma reported, “We are doing everything we can to fight the coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine.”
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 state of the art, 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 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. The expertise built up over this long history underpins hVIVO’s position as the market leader in the provision of human challenge studies.
Open Orphan Background
Open Orphan is a rapidly growing niche CRO pharmaceutical services company that is a world leader in testing vaccines and antivirals through the use of human challenge clinical trials, conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part. Volunteers are recruited through FluCamp. Learn more at www.FluCamp.com. The hVIVO facility offers highly specialized virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analyzing clinical samples. Robust quality processes support our team of scientists in the delivery of submission-ready data.
Call to Action: for those interested in volunteering in such a study, contact the following: www.UKCovidChallenge.com