Young healthy volunteers in the UK are to be infected with coronavirus as part of new cross-sector research which aims to accelerate the development of an effective vaccine, the government has announced.
Experts from the NHS, Imperial College London and the private sector are joining forces to establish so-called ‘challenge trials’, in which individuals are inoculated with a safe vaccine and then deliberately exposed to the virus within a controlled environment.
Critics have raised concern over the dangers of infecting people with a virus for which there is no current cure, but proponents of the study believe it has the potential to produce quicker results over which vaccines are effective.
The programme works differently to conventional vaccine field trials, which are more slow-moving as researchers must wait for participants to get infected within the wider community.
Business secretary Alok Sharma announced on Tuesday that the government will be investing almost £34m into the challenge trials, saying that the studies mark “an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines”.
The first stage of the project will be delivered by a partnership between Imperial College London, the Royal Free Hospital in London and HVivo, a subsidiary of Dublin-based pharmaceutical services company Open Orphan.
Known as the “characterisation study”, experts will attempt to establish the minimum dose of the virus required to cause a Covid-19 infection among healthy young people, aged between 18 and 30, who are at the lowest risk of harm.
This study, which is set to start in January at the Royal Free Hospital, is pending regulatory and ethical review, but up to 90 volunteers could be involved at this stage.
The participants will be examined by scientists to understand how the virus behaves in their body and interacts with their immune system, which will have been trained to fight the pathogen. Results are expected by May 2021.
Volunteers will be monitored for up to a year after participating in the study to ensure their long-term well-being.
Kate Bingham, chair of the government’s Vaccine Taskforce, said there is “much we can learn” about immunity and the length of protection offered by a vaccine.
“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,” she said.
Caroline Clarke, chief executive of the Royal Free London group, said she hoped that the new partnership “will advance the world’s understanding of Covid-19”.
She added: “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.”
HVivo said that participants would be infected with the strain of the virus that is currently circulating in the UK population, and that it had isolated this particular variant four months ago.
The pharmaceutical firm is to receive up to £10m from the government for helping to conduct the characterisation study, depending on the number of volunteers used. Participants will be compensated for their involvement in the trials, the government said.
Human challenge studies have been deployed in recent decades to accelerate the development of treatments and vaccines for diseases including malaria, typhoid, cholera, norovirus and flu.
The method was first trialled at the end of the 18th century, when English physician Edward Jenner exposed a young boy to smallpox after inoculating him with the cowpox virus. Smallpox is the only infectious disease to have been eradicated from the human population.
Dr Stephen Griffin, associate professor in the School of Medicine at the University of Leeds, said that the regulators and ethics committee would face a “difficult task” in granting approval for the research.
"Whilst the study wisely aims to recruit volunteers from younger age groups, there are albeit rare cases of severe and/or long lasting disease in this group for which we have no clear explanation,” he said. “As an effective rescue therapy does not yet exist for SARS-CoV2, there is a serious ethical dilemma for the MHRA committee to address here.
Jonathan Ball, a professor of molecular virology at the University of Nottingham, said that the outcomes of the study might “have limited wider relevance” given its focus on younger, healthier volunteers.
“The people we need to protect against serious disease are more vulnerable elderly people,” he added.
Professor Julian Savulescu, the co-director of the Wellcome Centre for Ethics and Humanities at the University of Oxford, said there was “a moral imperative to develop to a safe and effective vaccine – and to do so as quickly as possible”.
“The chance of someone aged 20-30 dying of Covid-19 is about the same as the annual risk of dying in a car accident. That is a reasonable risk to take, especially to save hundreds of thousands of lives. Given the stakes, it is unethical not to do challenge studies.”