20 October 2020
The Royal Free London (RFL) will play a key role in a world-leading partnership that is aiming to accelerate the development of vaccines and treatments for COVID-19.
The RFL has committed to the Human Challenge Programme, part of the government’s Vaccines Taskforce. It will be delivered through a partnership between RFL, government, Imperial College London, and hVIVO, an industry-leading clinical development services business that has pioneered human challenge models based upon viral challenge. The partnership is funded by the Department of Business, Energy, and Industrial Strategy.
Caroline Clarke, Royal Free London group chief executive, said: “We are proud to be part of this hugely important partnership, which we hope will advance the world’s understanding of COVID-19 as we look to rapidly develop life-saving vaccines and treatments. The Royal Free Hospital has a great history and tradition of treating and researching infectious diseases and our infectious diseases centre is renowned across the world for its work in this specialist area. We are looking forward to working alongside Imperial College London, BEIS, and hVIVO on such a vital piece of work over the coming months."
The first stage of this project will explore the feasibility of exposing healthy volunteers to the coronavirus. In this initial phase, the aim will be to discover the smallest amount of virus it takes to cause a person to become infected. This is known as a virus characterisation study.
This will take place at the Royal Free Hospital (RFH) and the study will be conducted under strict conditions – these include a controlled entrance to the facility, careful decontamination of waste and a dedicated laboratory for carrying out tests, all of which will help to ensure the study is delivered safely and securely. Air leaving the unit is also cleaned so there is no risk to anyone at the hospital or outside.
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 minimises the risk of harm.
Subject to ethics approval, the first study would start in early 2021 and focus on identifying the lowest levels of the virus needed to infect healthy consenting adult volunteers.
There are a range of services that the RFH will provide to support the running of the study These include space rental, maintenance, utilities, cleaning, catering, portering and security.
The RFH will also provide pharmacy, pathology, radiology, and cardiology support which will ensure shared learning.
Business Secretary Alok Sharma 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.”
Dr Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study, said: “Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines.
“Our number one priority is the safety of the volunteers. My team has been safely running human challenge studies with other respiratory viruses for over 10 years. No study is completely risk free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can.
“The UK’s experience and expertise in human challenge trials as well as in wider COVID-19 science will help us tackle the pandemic, benefiting people in the UK and worldwide."
Cathal Friel, Executive Chairman, Open Orphan, hVIVO’s parent company, 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.
“Our subsidiary hVIVO is the world leader in the testing of vaccines and antivirals using human challenge studies and our contract with the UK Government to develop a COVID-19 human challenge study model will safely accelerate the discovery of effective vaccines and antivirals against COVID-19. We hope our work will not just be valuable for the Company but will also help to reduce the impact of COVID-19 on the population.
“Our thoughts go out to all those that have been affected by the global COVID-19 pandemic.”
For more information on human challenge studies please visit https://www.hic-vac.org/public-information/human-challenge-studies-coronavirus-towards-effective-vaccines
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