LONDON - Experts from the NHS, academia and the private sector are today (20 October) joining forces with the government to explore and establish human challenge trials in the UK to speed up the development of a Covid-19 vaccine.
In human challenge studies, a vaccine candidate that has proven to be safe in initial trials is given to a small number of carefully selected healthy adult volunteers who are then exposed to the virus in a safe and controlled environment. Medics and scientists then closely monitor the effect on volunteers 24 hours per day to see exactly how the vaccine works and to identify any side effects.
As with all clinical studies in the UK, the proposed research will be carefully considered by regulators including the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS Health Research Authority through research ethics committees before any research starts.
Using controlled doses of virus, the aim of the research team will initially be to discover the smallest amount of virus it takes to cause Covid-19 infection in small groups of healthy young people, aged between 18 and 30, who are at the lowest risk of harm. Up to 90 volunteers, who are compensated for the time they spend in the study, could be involved at this stage.
Human challenge studies offer the chance to accelerate development of promising vaccines against Covid-19, bringing them to people more quickly – potentially saving thousands of lives.
The studies are 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 help to ensure the study is delivered safely and securely. All the air leaving the unit is also cleaned so there is no risk to anyone outside the unit.
Over many decades, human challenge studies have been performed safely and have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu. The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase 3 clinical trials that would follow, usually involving thousands of volunteers.
If approved by regulators and the ethics committee, the studies would start in January with results expected by May 2021.
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.”
Chair of the Government’s Vaccine Taskforce Kate Bingham said:
“This research will improve understanding of the virus, the biology of the disease, the signs that a person is protected from infection or developing the disease, the vaccine candidates, and will help in making decisions about research, that it is carried out safely and based on up-to-date evidence. There is much we can learn in terms of immunity, the length of vaccine protection, and reinfection.”
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."
Executive Chairman of Open Orphan, hVIVO’s parent company, Cathal Friel 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.”
Chief Executive of the Royal Free London group Caroline Clarke 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 treatments. The Royal Free Hospital has a great history and tradition of treating and researching infectious diseases and our 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.”
Deputy Chief Medical Officer Professor Jonathan Van-Tam said:
“A safe, fully approved, and meticulously controlled human challenge model for Covid-19 that is conducted by experienced experts may help in the search for safe and effective vaccines.
“First, for the many vaccines still in the mid-stages of development, human challenge studies may help pick out the most promising ones to take forward into larger Phase III trials.
“Second, for vaccines which are in the late stages of development and already proven to be safe and effective through Phase III studies, human challenge studies could help us further understand if the vaccines prevent transmission as well as preventing illness.”
Implementing Human Challenge studies
When strict conditions are met, there is global agreement through the WHO that human challenge studies can bring important wider societal benefits which should be considered by research ethics committees.
The first stage of this project will be delivered by a partnership between Imperial College London, the Royal Free Hospital’s specialist and secure research unit in London and industry-leading clinical company hVIVO, which has pioneered viral human challenge models.
The aim will be to discover the smallest amount of virus it takes to cause a person to develop Covid-19 infection. This is known as a virus characterisation study and will be backed by £33.6m of government investment.
The study will take place in world-class clinical facilities at the Royal Free 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 volunteer safety. Volunteers will be monitored for up to a year after participating in the study to ensure their long-term well-being.
Once this first phase is completed, researchers will deploy this human challenge model which will provide an unrivalled opportunity to study closely how vaccines work in the body to stop Covid-19.
Although other countries are considering human challenge studies for Covid-19, the UK is a leading country in the science behind and the delivery of these studies and will be the first to seek to establish them, with the necessary infrastructure and skilled workforce already in place.
It comes as the government is also investing £19.7 million in Public Health England (PHE) to scale up its capabilities in testing blood samples from clinical trials. The investment will fund vital equipment and a new, state-of-the-art laboratory facility at PHE Porton Down – this will accelerate essential testing to measure the effectiveness of Covid-19 vaccines currently in development.
These tests are an essential component in supporting the development and regulatory approval of vaccine candidates. PHE’s partner, Nexelis, will be providing scientific expertise and also conducting additional testing for the evaluation of Covid-19 vaccines.
The new investment will enable PHE Porton Down scientists to increase testing capacity, including evaluating individuals’ immune responses as part of the Human Challenge project.
Innovation Minister Lord Bethell said:
“This investment into new facilities at PHE Porton Down will enable its dedicated and expert scientists to accelerate the pace and scale of specialised testing to support the critical work of the Vaccine Taskforce.”
Head of Vaccine Research Projects at PHE Porton Down, Bassam Hallis said:
“This investment will accelerate the development of potentially life-saving vaccines to help get them to the public more quickly.”