Covid: human challenge trial in UK

Henrietta Strickland
October 22, 2020

Human challenge volunteers are paid and monitored for at least a year after.

Even if they are utilized, "human challenge trials would not replace Phase 3 trials" of COVID-19 vaccines, according to a September statement from the National Institutes of Health that called the standard, rigorous studies its priority.

Using controlled doses of virus, the aim of the research team will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are at the lowest risk of harm. This is known as a virus characterisation study.

In the USA, the National Institutes of Health has downplayed the need for challenge studies given the speed with which vaccines are being developed, but it has taken preliminary steps to prepare for such research in case the approach eventually is required.

In the spring, scientists hope to have more volunteers who will be given vaccines and exposed to the virus to see how well the vaccines work, the Post reported.

Chiu said the plan for initial studies - which are aimed at assessing how much virus it takes to infect someone with COVID-19 - is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.

Russian Federation boasted in August of licensing a coronavirus vaccine after less than two months of human trials, leading many experts to worry about its safety and efficacy. They can understand the biological markers of immunity.

British scientists are infecting healthy volunteers with the coronavirus, in hopes of speeding up vaccine development, the Washington Post reported Tuesday.

"Our number one priority is the safety of the volunteers". No study is completely risk-free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can. Faced with putting his life on hold indefinitely or the risk of catching COVID-19 by returning to university in the United Kingdom, the 22-year-old business student chose to roll up his sleeve and receive an experimental coronavirus vaccine. Before any research begins, the study must be approved by ethics committees and regulators. Viral insights Since the start of the global pandemic, doctors have learned a great deal about how the SARS-CoV-2 virus spreads and which groups may be at increased risk, as well as gaining clinical insights into treatments which can reduce the severity of disease and its complications.

During the same press briefing, the sector's executives rejected accusations that China does diplomacy with its vaccines and pointed out that President Xi Jinping himself promised that his Covid-19 vaccine would be a universal public good.

"Deliberately infecting volunteers with a known human pathogen is never undertaken lightly", said Peter Openshaw, co-investigator of the research. Advocates of the approach have pushed for its use in the study of vaccines against COVID-19 since early in the pandemic in the belief it can accelerate development.

England's Deputy Chief Medical Officer Professor Jonathan Van-Tam said a safe, fully approved, and meticulously controlled human challenge model for COVID-19 may help in the search for safe and effective vaccines. "These studies form a part of the global effort and play to a unique strength that we have at Imperial and in the UK".

Other reports by Click Lancashire

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