The UK will launch the world’s first coronavirus human challenge study which is set to start in the next few weeks.
The news was announced by the UK’s Department for Business, Energy and Industrial Strategy (BEIS) after the study was given the approval from the country’s clinical trials ethics body.
Researchers have called on all healthy, young people between the ages of 18 and 30 to take part in the study, which will play a major role in helping the development of effective Covid-19 treatments and vaccines.
The study which is being backed by a UK government investment of £33.6 million, will be the first-of-its-kind. It will see up to 90 carefully selected human adult volunteers, being exposed to the Covid-19 virus in a controlled and safe environment.
The initial trial will involve establishing the lowest amount of the virus that is needed to cause infection, probe the body’s immune response and explore how the virus is passed from person to person.
It will also help doctors understand how the immune system reacts to the virus and recognise factors that influence how Covid is transmitted, including how a person who is infected could transmit the infectious virus into the environment.
All of this information will give doctors a much greater understanding of the disease and therefore help in aiding the future development of treatment and vaccines.
Participants will be very closely monitored, with medics and scientists being on hand 24 hours a day to look after them. The team added that for the safety of the volunteers, the virus that will be used will be the variant that has been circulating in the UK since March 2020, not one of the newer mutant strains.
Once the initial trials are completed, the study will move on to expose participants that have already received a Covid vaccination.
The business secretary, Kwasi Kwarteng, said the study was an important element in efforts to tackle Covid.
“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,” he said.
“These human challenge studies 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 study’s chief investigator, Dr Chris Chiu from Imperial College London, said: “We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us.
“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work.”
Human challenge trials are not new. Over many decades, these studies have been carried out safely and have played a very important role in accelerating the development of treatments for diseases such as Typhoid, Flu, Malaria, Cholera and Norovirus.
These trials have also aided researchers to establish which vaccine is most likely to succeed in the phase 3 trials that would follow and usually involve thousands of volunteers.
The Human Challenge study is being carried out by a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the industry-leading clinical company hVIVO, which has pioneered viral human challenge models.
Interim Chair of the Vaccines Taskforce Clive Dix 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.”
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said: “Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the Covid-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.
"This study is a key enabling study to establish the Covid-19 challenge model and determine the lowest possible dose of virus required. Data from the study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.”
March 19, 2021