Britain will ‘host world’s first Covid-19 vaccine challenge trial’: Thousands of volunteers to be deliberately infected with the coronavirus to speed up tests of experimental jabs
- Controversial trials are said to be set to begin in January at facility in east London
- Volunteers will be infected with coronavirus a month after receiving a vaccine
- But with no proven treatment of mild illness, nothing to stop them falling very ill
British scientists will be the first in the world to carry out a controversial study in which healthy volunteers are infected with coronavirus, according to reports.
The ‘challenge trial’ – which could rapidly accelerate the development of experimental jabs – is said to be set to begin in January at a clinic in east London.
Participants will be infected with a dose of Sars-Cov-2, the virus that causes Covid-19, a month after being jabbed with a vaccine, according to the Financial Times.
The Government-funded study could help drugmakers test their Covid-19 vaccines without having to wait for volunteers to naturally catch the virus in the community.
Between 100 and 200 participants are expected to be recruited for the trial, which is being run by a US advocacy group that has campaigned for human Covid-19 challenge trials throughout the crisis.
It’s unclear which vaccine candidate will be tested, but Oxford University said that it was not involved in the programme. MailOnline has approached Imperial College London – Britain’s other jab frontrunner – for comment.
Challenge trials are commonly deployed by scientists trying to develop a vaccine and have been used in malaria, typhoid and flu. But, unlike those illnesses, there is no proven treatment for people with mild coronavirus, so there is nothing to stop the participants falling seriously ill.
Nobel Prize-winning scientists are among 100 experts calling for healthy people to be infected with coronavirus in a bid to speed up the development of vaccines (file)
The vaccine to be tested in the project has not been named, but organisers are said to have earmarked a 24-bed quarantine clinic run by hVivo in Whitechapel, London, to carry out the trials.
Drug researcher hVivo is linked to Queen Mary University of London while Imperial College London is the project’s academic leader.
Around 2,000 potential volunteers have signed up to take part in challenge studies in the UK.
WHAT ARE CHALLENGE TRIALS?
Challenge trials involve intentionally infecting healthy people with viruses then giving them a shot of a vaccine to see if the jab can clear the virus.
These studies have been done with many illnesses, including malaria, typhoid and flu.
But, unlike those illnesses, there is no treatment that prevents someone from falling badly ill with Covid-19.
Because of the ethical implications, so far none of the 23 clinical trials of coronavirus vaccines currently being carried out around the world have used the controversial study method.
Instead they are relying on participants who have caught the disease by accident in the community.
But because international lockdowns have been so effective, the number of people actually contracting the illness in the public is falling.
For this reason many studies are grinding to a halt.
Many projects – including Oxford University’s – have had to move their trials abroad where infection rates are higher.
Oxford is now testing he vaccine on 6,000 people in Brazil and South Africa – and hopes to have conclusive results by the end of the year.
This would mean a jab could be rolled out in early 2021.
They have done so through the US-based advocacy group 1Day Sooner, which is made up of 100 leading experts that includes Nobel Prize-winning scientists.
The group campaigns for Covid-19 infection trials and has enlisted 37,000 people worldwide. 1Day Sooner is currently petitioning for the controversial trials to be signed off by health regulators in the UK.
Any trials conducted in the United Kingdom have to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA told the FT: ‘Human challenge trials can be helpful for the development of vaccines and can provide early evidence of clinical efficacy, particularly when there are low rates of infection of the virus in the population.
‘The safety of trial participants is our top priority and any proposal from a developer to include a human infection challenge as part of a clinical trial for development of a vaccine would be considered on a benefit-risk basis, with risks monitored for and minimised in the proposed trial design.’
Vaccines are normally tested using two groups of people, both of which need to contract the disease naturally, with one given the vaccine and the other used as a control.
Both of Britain’s leading vaccine candidates are using the conventional methods, but they are being held up because so few people were being exposed to the disease during summer.
Traditional clinical trials require tens of thousands of participants to boost the chance of some of them being infected with coronavirus in the community.
But, in challenge trials, the pool of volunteers can be much smaller because every person is guaranteed to be injected with the disease.