British scientists are reported to be the first in the world to conduct a controversial study of healthy volunteers infected with coronavirus.
The "challenge attempt", which could quickly accelerate the development of experimental thrusts, is due 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, one month after being vaccinated, according to the Financial Times.
The government-funded study could help drug makers test their Covid-19 vaccines without waiting for volunteers to naturally catch the virus in the community.
It is expected that between 100 and 200 participants will be recruited for the study, which will be conducted by a U.S. advocacy group that advocated trials with human Covid-19 challenges during the crisis.
It is unclear which vaccine candidate will be tested, but Oxford University said it is not participating in the program. MailOnline reached out to Imperial College London – Britain's other front runner – for comment on its involvement.
Often conducted by scientists trying to develop a vaccine, challenge studies have been used for malaria, typhoid, and flu. However, unlike these diseases, there is no proven treatment for people with mild coronavirus, so it doesn't stop participants from getting seriously ill.
British scientists are reported to be the first in the world to conduct a controversial study of healthy volunteers infected with coronavirus
The vaccine to be tested as part of the project has not been named, but organizers are said to have designated a quarantine clinic operated by hVivo in Whitechapel, London, to conduct the trials. Drug researcher hVivo is affiliated with Queen Mary University of London, while Imperial College London is the academic director of the project.
Around 2,000 potential volunteers have signed up to take part in challenge studies in the UK.
They did this through the US-based advocacy group 1Day Sooner, which is made up of 100 leading experts, including Nobel Prize winners.
The group is committed to Covid-19 infection studies and has recruited 37,000 people worldwide. The controversial studies are currently being requested to be approved by the UK health authorities.
Studies conducted in the UK must be approved by the Medicines and Health Products Regulatory Authority (MHRA).
The MHRA told the FT: “Human challenge studies can be helpful for the development of vaccines and provide early evidence of clinical efficacy, especially when the virus infection rates in the population are low.
The hVivo laboratory in Whitechapel, east London (under construction), where the first tests are to take place
WHAT ARE CHALLENGE TRIALS?
Challenge attempts are used to purposely infect healthy people with virus and then give them a vaccine to see if the sting can clear the virus.
These studies were done on many diseases, including malaria, typhoid, and flu.
However, unlike these diseases, there is no treatment that will prevent someone with Covid-19 from becoming seriously ill.
Because of its ethical implications, none of the 23 coronavirus vaccine clinical trials currently being conducted worldwide have used the controversial test method.
Instead, they rely on participants who accidentally got the disease in the community.
But because international lockdowns have been so effective, the number of people who actually get the disease in public is falling.
Because of this, many studies stall.
Many projects – including that of Oxford University – have had to move their studies abroad, where infection rates are higher.
Oxford is currently testing the vaccine on 6,000 people in Brazil and South Africa – and it hopes to see conclusive results by the end of the year.
This would mean a sting could be introduced in early 2021.
& # 39; The safety of study participants is our top priority and any suggestion from a developer to include human infection as part of a clinical trial to develop a vaccine will be assessed on a risk-benefit basis, with the risks monitored and assessed the proposed test design is minimized. & # 39;
Scientists behind the Challenge study will need to select and purify a strain of coronavirus that is currently circulating in the UK population.
You must then decide on a dose that will infect the volunteer without causing serious illness.
This has been a sticking point so far as experts still disagree on what constitutes a “safe dose” of the virus, which only spilled over into humans earlier this year.
Some people infected with large amounts of the disease have no symptoms at all, while others are seriously unwell with much lower amounts – especially the elderly and those with compromised immune systems.
It is also important to have drugs on standby that can prevent serious illness in participants – another barrier to the approval of the trials.
To date, few steroids have been scientifically proven to treat Covid-19 – but they are only effective on sick patients and do nothing for people with moderately severe illness.
The London study initially uses remdesivir, an antiviral drug that has shown promise in preliminary studies. However, there is no concrete evidence that it works.
Those taking part in the study will likely be paid over £ 4,000, according to the FT. Individuals taking part in hVivo's Influenza Challenge Trials will receive up to £ 3,750.
Vaccines are usually tested on two groups of people who must both develop the disease naturally, one receiving the vaccine and the other acting as a control.
Both of the UK's top vaccine candidates are using conventional methods but are being held up because so few people were exposed to the disease over the summer.
Traditional clinical trials require tens of thousands of participants to increase the likelihood that some of them will become infected with coronavirus in the community.
In challenge studies, however, the pool of volunteers can be much smaller as each person is guaranteed to be injected with the disease.
In response to the news, Dr. Claire Waddington, Clinical Lecturer in Infectious Diseases at Cambridge University: “Challenge studies are well established to accelerate vaccine development for a wide range of infections.
“They are particularly useful when studying infections for which there are no reliable animal models or for which there is limited data on the immunobiology of a disease.
For example, for the past decade, a controlled human infection model for typhoid has been used to aid the development of typhoid vaccines, which are currently being introduced in high incidence countries and are likely to save thousands of lives.
& # 39; Controlled human infection models have the advantage that we know exactly when people are exposed to the pathogen of interest, so that the response to infection and the protection of all vaccines used in the model can be studied directly and precisely.
“Safety is always paramount in these studies, as it is in any human study.
& # 39; As the understanding of Covid-19 increases, we are increasingly able to identify those individuals in whom Covid-19 infection is a mild illness, and those individuals could safely participate in a controlled infection study after a thorough medical examination participate in people consent process.
"Such a model could give us some extremely useful information about how the immune system responds to COVID and what responses are protective, as well as providing a model for early screening of vaccine candidates."
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