Challenge trial volunteer reveals he’ll be cooped up for two weeks to test trial Covid-19 jabs as Oxford expert praises controversial experiment
- Challenge trial will take place at a clinic in east London, it was reported
- Some 100 to 200 Britons have volunteered to take part in the controversial study
- It could accelerate the development of an effective vaccine against Covid-19
- Vaccine to be used has not been revealed, but it will not be Oxford University’s
One of the volunteers for a controversial vaccine trial where they will be deliberately infected with coronavirus revealed they will be locked up for two weeks to stop them spreading the disease.
In the challenge trial, participants will receive a jab before being exposed to a dose of SARS-CoV-2 a month later. They will then be kept at a clinic in east London for two weeks to monitor their progress.
Some of the 100 to 200 Britons taking part in the study, which will be launched in January, may remain behind closed doors for ‘considerably longer’ if their symptoms of the virus do not subside.
Trial volunteer Alastair Fraser-Urquhart, 18, told the BBC Radio 4’s Today programme he signed up because the experiment has the potential to save ‘thousands of lives’ and ‘bring the world out of the pandemic sooner’.
The world-leading study — yet to be officially confirmed by the government — could rapidly accelerate the approval of a vaccine, and will be the first of its kind carried out anywhere in the world.
It’s unclear which vaccine candidate will be tested, but drug giants AstraZeneca —which is developing the Oxford vaccine — and Sanofi — which says its vaccine may be ready before next June — have insisted they are not taking part.
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.
British scientists will be the first in the world to carry out a controversial study in which healthy volunteers are infected with coronavirus
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.
Mr Fraser-Urquhart told the Today programme this morning he could ‘certainly imagine’ his time locked in the clinic ‘could push the two week boundary’.
‘I’ll be remaining at the clinic, really, for as long as it takes,’ he said. ‘Obviously we can’t have it infecting anyone who isn’t a part of the trial, so every volunteer would need to be held in bio-containment.’
Explaining why he signed up, he said the trial has the potential to save ‘thousands of lives’ and ‘bring the world out of the pandemic sooner’.
He added: ‘It was just something that made instant sense to me, really.’
Challenge trials have been used in the past to check whether vaccines are effective for diseases including smallpox, malaria and influenza.
The first time they were used dates back to the 18th century, when Edward Jenner inoculated an eight-year-old boy with the cowpox virus and then exposed him to smallpox to see whether it protected him from the disease.
‘There really is a long history of doing this,’ said Professor Peter Horby, a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG). ‘It has the real potential to advance science and get us to a better understanding of the disease and vaccines faster.’
Challenge trials were initially avoided for coronavirus over fears of the virus’ impact on participants exposed to it.
But research has made the trials possible as it has revealed young, healthy volunteers with no underlying health conditions are at ‘extremely low’ risk of dying from the virus, and identified treatments reducing the risk of death from the disease such as remdesivir.
Professor Horby, from Oxford University, said that in the trial the immune response will be measured in volunteers blood before they are challenged.
‘If they’re protected, then we can say that the blood markers are reliable markers of protection, then we can use those in further studies to expand the patient group to other groups as well, which is much easier than trying to identify proper infection in trials in the community.’
The vaccine to be tested in the project has not been named, and organisers are said to have earmarked a 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 understood to be the project’s academic leader.
Around 2,000 people have signed up for the trial through 1Day Sooner, a US-based advocacy group made up of 100 leading experts including Nobel Prize-winning scientists.
The group is currently petitioning for the controversial trials to be signed off by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
They said in a statement: ‘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.’
Those taking part in the trial could be paid more than £4,000. People who participate in the influenza vaccine trials are paid up to £3,750.
Reacting to the news, Dr Claire Waddington, clinical lecturer in infectious diseases at the University of Cambridge, said: ‘Challenge trials are well established as a way to accelerate the development of vaccines for a wide range of infections.
‘As we gain more understanding of Covid-19, we are increasingly in a position to identify those people for who Covid-19 infection is a mild illness, and these people could safely participate in a controlled human infection study after a thorough medical assessment and consent process.
‘Such a model could give us some extremely useful information on how the immune system responds to Covid-19 and what responses are protective, as well as providing a model for early testing of candidate vaccines.’
How scientist Edward Jenner used eight-year-old son of his gardener for the first ever challenge trial
Edward Jenner pictured in a portrait
Esteemed scientist Edward Jenner used the eight-year-old son of his gardener for the first ever challenge trial, with just a hunch as to whether it would be successful.
Luckily, it worked. And the study led to the invention of the smallpox vaccine, which saw the debilitating disease eradicated in 1977, more than a hundred years later.
The life-threatening condition caused fever, vomiting, mouth sores and fluid filled blisters to appear on the skin which would then develop scabs.
Victims would be left with life-long scarring on their skin, and 30 per cent of all those suffering from the disease would eventually die.
But, after the vaccine was administered worldwide, deaths from smallpox plunged from 150million in the 1950s to zero today.
How did the first challenge trial come about?
Edward Jenner had the idea for the trial after hearing about an old country tale, which said milkmaids who caught cowpox from the animals would never catch smallpox.
Cows infected with the mild infection had a few weeping spots (pocks) on their udders, but suffered little discomfort. Milkmaids occasionally caught it from their animals and felt off-colour for a few days, but could then return to work unscathed.
Mr Jenner thought he would test the affect of cowpox as a vaccine by purposefully infecting someone with it, and then exposing them to smallpox so he could monitor their response.
What happened in the first challenge trial?
In May 1796 a milkmaid, Sarah Nelmes, came to Mr Jenner about a rash that had appeared on her hand. He diagnosed cowpox and Ms Nelmes confirmed that one of her cows, Blossom, had recently suffered from the disease.
Spotting his chance Mr Jenner asked his gardener’s eight-year-old son, James Phipps, to take part in the experiment. On May 14 he made a few scratches in the boy’s arm and inserted some skin samples from the rash on Ms Nelmes’ hand.
The boy then became mildly ill with cowpox, but recovered a few days later.
On July 1 Mr Jenner exposed his gardener’s son to smallpox, to discover whether his trial had been successful. Fortunately, the boy did not develop smallpox on that occasion, or the many times he was tested afterwards.
Source: The Jenner Institute
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