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World’s First Coronavirus Human Challenge Study Wins Ethics Approval in UK

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The first Covid-19 Human Challenge study begins within a month after receiving ethics approval in the same week. The UK has achieved its primary target for 15 million people. Researchers ask healthy young people to volunteer for research. Role in the development of effective Covid-19 vaccines and treatments Up to 90 volunteers aged 18-30 are exposed to Covid-19 in a safe and controlled environment to increase their understanding of the virus’s impact on people.

The first study of the virus, backed by 33.6 million UK government investment, helped doctors better understand Covid-19 and support pandemic response, including establishing the minimum amount of virus needed to cause infection. Will be. Support vaccine and treatment development.

It is expected to begin in the coming weeks, and up to 90 carefully selected healthy adult volunteers will be exposed to the virus in a safe and controlled environment.

Volunteer safety is paramount. That said, this virus characterization study initially used a version of the virus that has been in circulation in the UK since March 2020 and found it to be at low risk in healthy young adults. Medics and scientists will closely monitor the effects of the virus on volunteers and take care of them 24 hours a day.

The researchers also work very closely with the Royal Free Hospital and North Central London (NCL) Adult Critical Care Network to ensure that this study does not affect the NHS’s ability to care for patients during the epidemic. Research does not start without progress.

When this initial study is conducted, vaccine candidates that have been proven safe in clinical trials can be provided to a small number of volunteers exposed to the Covid-19 virus to identify the most effective vaccine and accelerate it. Development.

Researchers recommend that people aged 18 to 30 who have the lowest risk of complications from coronavirus volunteer for this important study. Volunteers are rewarded for their time spent on research.

Business Minister Kwasi Kwarteng said:

Researchers and scientists around the world have made tremendous progress in understanding Covid-19 and developing important vaccines to protect people.

Although very positive progress has been made in vaccine development, we want to find the best and most effective vaccines that can be used in the long term. These human challenge studies will be conducted in the UK and could accelerate scientists’ knowledge of the impact of coronavirus on people and ultimately promote the rapid development of vaccines.

For decades, human challenge research has been conducted safely and has played a significant role in accelerating the development of treatments for diseases including malaria, typhoid fever, cholera, norovirus and flu. The trials also helped researchers establish the vaccines most likely to succeed in phase 3 clinical trials, typically involving thousands of volunteers.

This initial study also helps doctors understand how the immune system responds to the coronavirus and identifies factors that affect the way the virus is transmitted, including how people infected with the Covid-19 virus deliver infectious virus particles into the environment. Will help you.

The Human Challenge study is delivered through a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust, and hVIVO, an industry-leading clinical company that pioneered the viral human challenge model.

London’s Royal Free Hospitals experts and safe clinical research facilities are specifically designed to contain the virus. Highly trained medical staff and scientists will carefully investigate how the virus works in the body and will be on standby to ensure the safety of volunteers.

The virus used in the characterization study was produced by the team of Great Ormond Street Hospital for Children NHS Foundation Trust in London in collaboration with hVIVO, with the support of a virologist at Imperial College London.

The interim chairman of the Vaccines Taskforce Clive Dix said:

While we have secured several safe and effective vaccines for the UK, it is essential to continue developing new vaccines and treatments for Covid-19. We expect these studies to provide unique insights into how the virus works and to help us understand which promising vaccines offer the best chances to prevent infection.

Chief Researcher Chris Chiu of Imperial College London said:

We are asking volunteers aged 18 to 30 to participate in this research work and help them understand how the virus infects people and how it is transmitted successfully between us. Our ultimate goal is to establish the most effective vaccines and treatments to fight this disease, but we need volunteers to support this work.

Dr Andrew Catchpole, hVIVO’s Chief Scientific Officer, said:

Ethical review of the study plan is an important part of conducting clinical research, and approval by the Ethics Committee marks a very important milestone in the development of the Covid-19 challenge model. COVID-19 Human Challenge research has the potential to play an important role in providing data and information to help continue developing vaccines to control the pandemic.

This study is a key study in establishing the Covid-19 challenge model and determining the minimum viral dose required. The data from this study not only immediately facilitates the challenge model used in vaccine efficacy testing, but can also answer a wide range of basic science questions that cannot be realized with traditional field trials, such as exactly what type of immunological response is required. Protection from reinfection.

People can express their interest in participating in this study at https://ukcovidchallenge.com/.

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