Laura Gallagher, Imperial College
The UK will be the first country to run a Covid-19 human challenge study, following a favourable opinion from the UK’s clinical trials ethics body.
Backed by a £33.6 million UK government investment, the study will be delivered by a partnership between Imperial College London, the Royal Free London NHS Foundation Trust and the clinical company hVIVO.
The initial study will help scientists understand how the immune system reacts to coronavirus (the virus that causes Covid-19), and identify factors that influence how the virus is transmitted – including how a person who is infected ‘sheds’ infectious virus particles into the environment.
It will involve up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment. Researchers are encouraging people aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, to consider volunteering to take part.
Once the initial study has taken place, vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to Covid-19, helping to identify the most effective vaccines and accelerate their development.
Understanding the virus
The initial study will aim to establish the least amount of virus needed to cause Covid-19 infection. As there is much less information available about new virus variants, the doctors will use the original virus that has been circulating in the UK since March 2020. The study will only involve volunteers who are young and healthy as we know that this group of people are at very low risk of becoming severely ill from coronavirus infection. The studies will take place in a specialised unit with very close monitoring and with medics on hand with treatments if they are needed.
The initial study has been reviewed by the Health Research Authority to ensure that it meets the highest ethical standards. The safety of the volunteers is of utmost importance and their health will be closely monitored throughout their time in the purpose-built quarantine unit. Volunteers will also be followed up for a year after their participation.
Chief Investigator Dr Chris Chiu, from the Department of Infectious Diseases at Imperial College London, said: “We are asking for volunteers aged between 18 and 30 to join this research endeavour to help us to understand how the virus infects people and how it passes so successfully between us. Our eventual aim is to quickly test which vaccines and treatments work best in beating this disease.”
Business Secretary Kwasi Kwarteng said: “Researchers and scientists around the world have made great progress in understanding Covid-19 and developing critical vaccines to protect people, but we are only partway up the mountain we need to climb.
“While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term. These human challenge studies – the world’s first – will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines.”
The Royal Free Hospital’s specialist and secure clinical research facilities in London are specifically designed to contain the virus. Highly trained medics and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure the safety of volunteers. The researchers are also working very closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact on the NHS’ ability to care for patients during the pandemic. The virus characterisation study will not begin without their go-ahead.
The virus being used in the characterisation study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust, with support from virologists from Imperial.
The Chair of the Vaccines Taskforce Clive Dix said: “No one vaccine is likely to be suited to everyone so we must continue to develop new vaccines and treatments for Covid-19 coronavirus. This will help us to ensure that people across the UK and the world can be protected against this disease. 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.”
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said: “We will start to see useful results very quickly after the commencement of the study. From the moment we inoculate someone with this virus, we will learn important information about disease progression and treatment. This crucial data feeds directly back into how to develop effective vaccines and better treatments because they identify what type of immune response needs to be triggered.”
People can express an interest in taking part in this research at https://ukcovidchallenge.com/