Researchers in London-UK plan to start infecting healthy volunteers with a tightly controlled dose of coronovirus in early 2021, with a first to more quickly reduce the effectiveness of multiple vaccines against Kovid-19 – said attempt.
The so-called human-challenge trials are planned to target 18- to 30-year-old children who are free of Kovid-19 symptoms and show no other risk factors, such as heart disease or diabetes, the researchers said led to the infectious disease Imperial College. Experts from London, who are overseeing the effort.
Scientists around the world have debated for months whether intentionally infecting healthy people with the virus that causes Kovid-19 is at a much higher risk and therefore unethical.
Some researchers argue that the severity of the epidemic, including deaths and economic tolls, justifies over-invasive testing methods. But others say there are too many unknowns: persistently young, healthy people sometimes suffer from extreme Kovid symptoms, and there is no proven treatment for subjects who fall seriously ill.
What’s more, the increased infection rate means that potential test subjects already have the virus, so there may be no need to intentionally inject it into more people. “We must question whether a direct challenge study is necessary,” says Stephen Griffin, an antiviral researcher and associate professor of medicine at the University of Leeds.
The debate over vaccination of humans with living, powerful viruses has been going on for centuries. In a famous experiment in the late 1700s, the British doctor Edward Jenner injected a child with the smallpox virus, then recorded details of the boy’s reaction.
UK researchers said on Tuesday that independent ethics and health committees would first have to approve the study before enrolling volunteers, and they would closely monitor every stage from participant screening to injection, isolation and follow-up. The researchers also said they would seek approval from the UK regulatory body responsible for the safety of medicines and medical devices.
The group of researchers stated that initially test subjects would be separated and compensated for two to two and a half weeks. Scientists initially plan to start volunteers with the smallest dose until they find a level that reliably causes infection. The virus will be injected through the nose as droplets.
Scientists said the first phase of the study did not include the vaccine. After researchers better understand the level of infection and participant responses, they will integrate the vaccines to measure their effectiveness when volunteers are confronted with the virus.
Proponents of challenge trials say they are necessary to accelerate the epidemic to allow for vaccine clearance and fine-tuning, and a better understanding of the disease. Typically vaccines can take eight to 10 years to develop. Kovid-19 has accelerated the rapid research and testing of experimental vaccines in a fraction of the time to save lives and jump economies. Leading Kovid-19 vaccine candidates have progressed to late-stage testing and may be available if the emergency authority is asked, in early December, the companies developing them.
Researchers at the planned UK Challenge trial said they had not identified which vaccine candidates they would use, adding that the challenge study did not replace traditional vaccine clinical trials that rely on participants to naturally Be exposed to viruses.
During the challenge trial, treatments, which will initially include antiviral drug remedivir, will be prepared and administered even before volunteers show symptoms in an effort to limit the risk of critical illness, Drs. Chris Chiu, principal researcher at Imperial College, said in a media briefing on Tuesday of the study.
A recent multicountry study funded by the World Health Organization found that the number of deaths from Kovid-19 in hospitalized patients did not decrease.
But Dr. Chiu said the researchers believe the pre-pathological condition of the challenge-study volunteers, along with their young and strong physical condition, will make Remedisvir a “pre-emptive treatment”.
The UK government said it has agreed to provide £ 33.6 million, the equivalent of $ 43.5 million in funding, and aims to start trials in January with possible results by January 2021.
Pioneer Kovid-19 vaccines in development include one produced by Cambridge, Mass. – based Modern Inc.
And another co-developed by Pfizer Inc.
And Biotech SE.
Large US trials for two other major Kovid-19 vaccines from Johnson & Johnson and AstraZeneca plc, working in partnership with the University of Oxford – have been halted while investigating unexplained diseases between companies and independent panel study subjects We do.
Scientists and UK government officials are hopeful that late-stage trials of their vaccine candidate sponsored by Oxford – which was temporarily halted but have since resumed – could show results by the end of this year. If so, Oxford and AstraZeneca can seek emergency authorization for a shot through UK or European authorities.
Researchers and colleagues at Imperial College said they saw a significant number of volunteers for the challenge trials. Because participants will be in extreme physical condition, many are expected to be infected with coronovirus, but show mild symptoms or none at all.
The scientists said the hope is to first focus on the healthiest areas of the population, hoping that their reactions will guide researchers to the best vaccines and treatments for more vulnerable groups.
Write Jenny Strasburg at [email protected]
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