The Human Challenge Programme, part of the government’s Vaccine Taskforce, is a partnership between the government, the NHS, academia and the private sector to establish human challenge studies for COVID-19 in the UK.
The programme is funded by Department of Business, Energy, and Industrial Strategy (BEIS) through the Vaccine Taskforce and will be delivered through a partnership between government, hVIVO, Imperial College London, and The Royal Free London NHS Foundation Trust.
This partnership will explore the use of human challenge studies to improve and accelerate the development of vaccines and treatments against COVID-19 and will create a UK-based infrastructure for future human challenge trials supporting the world’s biotech and pharmaceutical industries.
The first stage of this project will explore the feasibility of exposing healthy volunteers to COVID-19. In this initial phase, called the Virus Characterisation Study, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19. The study will be sponsored by Imperial College London and conducted by hVIVO at the Royal Free Hospital’s specialist research unit in London, under the scrutiny of hVIVO’s highly trained scientists and medics. If the COVID-19 research is approved by regulators, it will begin early next year with results expected by May 2021.
hVIVO’s, state of the art facility at Queen Mary’s Bioenterprise Centre, London, is booked to maximum capacity until Summer 2021 and will continue to be used to deliver the Company’s traditional challenge study contracts, particularly respiratory syncytial virus (RSV).
Once the characterisation study is completed, this Human Challenge Study model can be utilised to conduct COVID-19 Human Challenge Studies from mid-2021 subject to regulatory approvals.
About Human Challenge Studies
In human challenge studies a small number of healthy volunteers in a controlled setting are exposed to an infectious agent, in this instance, COVID-19, and scientists and medics assess how effective vaccines or treatments are against the disease and identify any side effects.
Human Challenge Studies have been safely carried out for many years and played important roles in progress against diseases including malaria, typhoid, cholera, norovirus and flu. They are among the most efficient and scientifically powerful means for testing vaccines. hVIVO has safely completed 50 Human Challenge Studies since it was established in 1989 which included inoculating over 3,000 volunteers using viruses such as Influenza, Respiratory Syncytial Virus and Human Rhinovirus.
Normally, challenge studies only happen when effective treatments for a disease are available, which makes infecting healthy people with COVID-19 ethically complex. But BEIS is backing the partnership and a human challenge model because COVID-19 poses an extraordinary threat to public health and the socioeconomic stability to the UK.
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. The human challenge study will be reviewed by a specially convened ethics committee before any volunteers are enrolled and the Medicines and Healthcare products Regulatory Agency (MHRA), an exemplar globally of medicines and device regulation, will approve the study before it is conducted.
Participants in the initial study will be carefully selected to exclude anyone with a characteristic that has been shown to increase the severity of COVID-19 infection. To sign up to be notified about any potential future COVID-19 challenge studies visit www.UKCovidChallenge.com.
The study will take place in a clinical facility that allows doctors to monitor volunteers 24 hours per day and have immediate receipt of medical care if required. Volunteers will be monitored for up to a year after receiving the virus, to ensure their long-term well-being.
The prevalence of COVID-19 rises and falls in populations, making it difficult for traditional vaccine trials to assess if vaccines work because those testing the vaccine may not be naturally exposed to it; as Human Challenge Studies deliberately infect the volunteers it is possible for scientists to establish efficacy very quickly.
Human Challenge Studies help the selection of the most effective vaccines because they make it possible for scientist to compare the efficacy of vaccine candidates, by testing them side by side to establish which is more effective.