World 'Two thousand' sign up to be infected with COVID in UK vaccine trial

13:11  24 september  2020
13:11  24 september  2020 Source:   news.sky.com

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During the trial , volunteers will be inoculated with an experimental vaccine , before receiving a “challenge” dose of Sars-Cov-2 – the virus that causes Covid -19 Healthy young adults – deemed to be at low risk from the effects of the virus – will be used in the trial , while antiviral drug remdesivir will

'Human challenge trials ' to test the effectiveness of possible Covid vaccines may be held in The UK could be the first country in the world to carry out Covid "challenge trials " - where healthy volunteers What's been holding things up are ethical considerations - challenge studies have been used to test

a blue toothbrush: The trials are due to start next year. File pic © Getty The trials are due to start next year. File pic British volunteers are to be deliberately infected with COVID-19 to test whether a vaccine offers any protection.

In the first trial of its kind, participants will be injected with an experimental vaccine and around a month later exposed to Sars-Cov-2, the virus that causes the disease.

According to FT, the studies - which are known as human challenge trials - will begin in January and are government funded.

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COVID -19 vaccine trials use a design known as “randomized, blinded, placebo-controlled” studies, in which people who are more likely to be exposed Because it is not known if the vaccine is effective, it has to be done in a randomized controlled trial . This means that without knowing what group they fall

When the Oxford vaccine began in April, only two volunteers were immunised on the first day. If there are to be enough doses to protect the world, several vaccine approaches will need to be Related Internet links. Imperial COVID -19 Vaccine Trial . The BBC is not responsible for the content

It is reported that the trials will take place in a secure facility in Whitechapel, east London, and that 2,000 potential volunteers have signed up in the UK.


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A government spokesperson said it is looking into collaborating on the potential development of a vaccine through human challenge studies.

"These discussions are part of our work to research ways of treating, limiting and hopefully preventing the virus so we can end the pandemic sooner," they added.

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Conventional vaccine trials typically consist of three phases -- the first, in which fewer than 100 participants are dosed to determine the safety; the second, in which the number of participants ramps up into the hundreds; and the third, in which the study is broadened to include thousands of people.

Any trial that involves exposing people to the virus would need the approval of the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as an independent research committee.

a man standing in front of a computer: Around 2,000 people are thought to have volunteered © Getty Around 2,000 people are thought to have volunteered

Challenge trials are controversial.

Even young people have a very small risk of serious disease from the virus and some doctors believe that goes against medical ethics.

There is also the risk they could suffer from "long COVID" symptoms similar to chronic fatigue syndrome.

But with levels of the virus spreading in the population still relatively low, the trials are the fastest way of testing the level of protection from a vaccine.

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Scientists need to know whether the vaccines being developed stop people getting the virus, or whether they just take the edge off symptoms.

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".

She pointed to similar trials being used for typhoid vaccines, which are now being rolled out in affected countries.

"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," she said.

"Such a model could give us some extremely useful information on how the immune system responds to COVID and what responses are protective, as well as providing a model for early testing of candidate vaccines."

The MHRA said: "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."

Stay alert to stop coronavirus spreading - here is the latest government guidance. If you think you have the virus, don't go to the GP or hospital, stay indoors and get advice online. Only call NHS 111 if you cannot cope with your symptoms at home; your condition gets worse; or your symptoms do not get better after seven days. In parts of Wales where 111 isn't available, call NHS Direct on 0845 46 47. In Scotland anyone with symptoms is advised to self-isolate for seven days. In Northern Ireland, call your GP.

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usr: 3
This is interesting!