Open Orphan: World’s first COVID-19 human trials given green light in the UK

Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announced the world’s first COVID‐19 characterisation study has received approval from a specially convened Research Ethics Committee (“REC”). This news follows the announcement on 20 October 2020 of Open Orphan subsidiary hVIVO’s contract with the UK Government to develop a COVID‐19 human challenge study model.

The initial virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID‐19 (SARS‐CoV‐2) infection in a safe and controlled environment. The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust’s specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.

Clive Dix, chair of the Vaccines Taskforce, said: “We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19.

We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.

Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief Investigator of this study said: “The recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively have raised new questions about COVID-19 and how to best protect ourselves against it. This study will immediately tell us about mild and asymptomatic infection, which is a major driver of continuing transmission. While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus.”

“The Research Ethics Committee has provided detailed independent scrutiny. Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research.”

To read the article on BBC News click here.

For read the full press release click here.