Covid 19 coronavirus: United Kingdom to infect healthy volunteers in vaccine research trial

Open Orphan to develop UK Covid-19 human challenge study model

UK paves way for first tests to expose people to coronavirus

Researchers in Britain are preparing to start a controversial COVID-19 "human challenge" study in which dozens of healthy volunteers will be exposed to live coronavirus in an effort to speed up vaccine development.

The UK government said on Tuesday that it will invest 33.6 million British pounds ($43.5m) in the Human Challenge Programme in partnership with Imperial College London, laboratory and trial services company hVIVO, and the Royal Free London NHS Foundation Trust.

Regulators and an ethics committee will have to approve the challenge trials before they can begin next year, and an announcement said results are "expected by May 2021".

In the first phase of the United Kingdom challenge study, researchers will expose 90 paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19.

Several potential vaccines are already nearing the end of traditional phase 3 trials using "natural" exposure to the virus, but simply showing that as vaccine has some effectiveness in preventing the onset of COVID-19 does not mean it is the best that scientists can do.

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"Any studies involving the novel coronavirus will focus on those most likely to experience a mild infection - young healthy volunteers", he said in a press release from the Science Media Centre.

The Imperial College lead researcher on the project, Dr. Chris Chiu, insists the safety of the volunteers is the number one priority. "Second, for vaccines which are in the late stages of development and already proven to be safe and effective through phase 3 studies, human challenge studies could help us further understand if the vaccines prevent transmission as well as preventing illness", Jonathan Van-Tam, the U.K.'s deputy chief medical officer, said in a statement. "The funding announced today for these ground-breaking but carefully controlled studies marks an important step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life".

"Deliberately infecting volunteers with a known human pathogen is never undertaken lightly", said Professor Peter Openshaw, co-investigator on the study.

"Vaccinating the world against COVID-19 will be one of the largest mass undertakings in human history, and we will need to move as quickly as the vaccines can be produced".

"Participants in the initial study will be carefully selected to exclude anyone with a characteristic that has been shown to increase the severity of COVID-19 infection", hVIVO said in a statement.

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"The notion of eliminating Covid from anywhere is not right, because it will come back", he said, noting there had only been one human disease "truly eradicated" thanks to a highly effective vaccine and that was smallpox.

Biotech companies and academic bodies around the world have joined forces to try to create a vaccine against the coronavirus at breakneck speed given its ferocity. The rate of severe COVID-19 in healthy people aged 18 to 30 is low, but it is plausible that a volunteer will react badly to being infected with SARS-CoV-2.

The research will be conducted at the Royal Free Hospital in London, which has a specially designed area to contain the disease.

Volunteers will be monitored for up to a year after taking part in the study, in order to check for any side-effects.

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