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Expert partnership to explore and establish Human Challenge studies of COVID-19 in the UK | |
admin | |
2020-10-20 | |
发布年 | 2020 |
语种 | 英语 |
国家 | 英国 |
领域 | 气候变化 ; 资源环境 |
正文(英文) |
Press release
Expert partnership to explore and establish Human Challenge studies of COVID-19 in the UK£33.6 million government investment will back the studies in partnership with Imperial College London, hVIVO and the Royal Free London NHS Foundation Trust. ![]()
Experts from the NHS, academia and the private sector are today (20 October) joining forces with the government to explore and establish human challenge trials in the UK to speed up the development of a COVID-19 vaccine. In human challenge studies, a vaccine candidate that has proven to be safe in initial trials is given to a small number of carefully selected healthy adult volunteers who are then exposed to the virus in a safe and controlled environment. Medics and scientists then closely monitor the effect on volunteers 24 hours per day to see exactly how the vaccine works and to identify any side effects. As with all clinical studies in the UK, the proposed research will be carefully considered by regulators including the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS Health Research Authority through research ethics committees before any research starts. 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. Up to 90 volunteers, who are compensated for the time they spend in the study, could be involved at this stage. Human challenge studies offer the chance to accelerate development of promising vaccines against COVID-19, bringing them to people more quickly – potentially saving thousands of lives. The studies are conducted under strict conditions – these include a controlled entrance to the facility, careful decontamination of waste and a dedicated laboratory for carrying out tests, all of which help to ensure the study is delivered safely and securely. All the air leaving the unit is also cleaned so there is no risk to anyone outside the unit. Over many decades, human challenge studies have been performed safely and have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu. The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase 3 clinical trials that would follow, usually involving thousands of volunteers. If approved by regulators and the ethics committee, the studies would start in January with results expected by May 2021. Business Secretary Alok Sharma said:
Chair of the government’s Vaccine Taskforce Kate Bingham said:
Dr Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study, said:
Executive Chairman of Open Orphan, hVIVO’s parent company, Cathal Friel said:
Chief Executive of the Royal Free London group Caroline Clarke said:
Deputy Chief Medical Officer Professor Jonathan Van-Tam said:
Implementing Human Challenge studiesWhen strict conditions are met, there is global agreement through the WHO that human challenge studies can bring important wider societal benefits which should be considered by research ethics committees. The first stage of this project will be delivered by a partnership between Imperial College London, the Royal Free Hospital’s specialist and secure research unit in London and industry-leading clinical company hVIVO, which has pioneered viral human challenge models. The aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19 infection. This is known as a virus characterisation study and will be backed by £33.6 million of government investment. The study will take place in world-class clinical facilities at the Royal Free specifically designed to contain the virus. Highly trained medics and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure volunteer safety. Volunteers will be monitored for up to a year after participating in the study to ensure their long-term well-being. Once this first phase is completed, researchers will deploy this human challenge model which will provide an unrivalled opportunity to study closely how vaccines work in the body to stop COVID-19. Although other countries are considering human challenge studies for COVID-19, the UK is a leading country in the science behind and the delivery of these studies and will be the first to seek to establish them, with the necessary infrastructure and skilled workforce already in place. It comes as the government is also investing £19.7 million in Public Health England (PHE) to scale up its capabilities in testing blood samples from clinical trials. The investment will fund vital equipment and a new, state-of-the-art laboratory facility at PHE Porton Down – this will accelerate essential testing to measure the effectiveness of COVID-19 vaccines currently in development. These tests are an essential component in supporting the development and regulatory approval of vaccine candidates. PHE’s partner, Nexelis, will be providing scientific expertise and also conducting additional testing for the evaluation of COVID-19 vaccines. The new investment will enable PHE Porton Down scientists to increase testing capacity, including evaluating individuals’ immune responses as part of the Human Challenge project. Innovation Minister Lord Bethell said:
Head of Vaccine Research Projects at PHE Porton Down, Bassam Hallis said:
Notes to editorsHuman challenge studies have been performed safely over several decades in thousands of consenting volunteers in other disease areas such as typhoid, cholera, and influenza. They differ from standard clinical trials in which volunteers are vaccinated to see if they develop a disease circulating in the community over several months. In human challenge studies, a smaller group of volunteers is exposed to an infection after they have been vaccinated. About the government’s Vaccine TaskforceThe government’s Vaccine Taskforce (VTF) was set up under the Department for Business, Energy and Industrial Strategy (BEIS) in May 2020, to ensure that the UK population has access to clinically effective and safe vaccines as soon as possible, while working with partners to support international access to successful vaccines. This is to place the UK at the forefront of global vaccine research, development, manufacture and distribution. The Vaccine Taskforce comprises a dedicated team of private sector industry professionals and officials from across government who are working at speed to build a portfolio of promising vaccine candidates that can end the global pandemic. It is chaired by biotech and life sciences expert Kate Bingham, who was appointed by the Prime Minister Boris Johnson. The Vaccine Taskforce’s approach to securing access to vaccines is through:
About Public Health EnglandPHE exists to protect and improve the nation’s health and wellbeing and reduce health inequalities. It does this through world-leading science, research, knowledge and intelligence, advocacy, partnerships and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the Department of Health. It provides government, local government, the NHS, Parliament, industry and the public with evidence-based professional, scientific and delivery expertise and support. For more information on PHE visit www.gov.uk/phe or follow on Twitter.
Published 20 October 2020
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来源平台 | Department for Business, Energy & Industrial Strategy |
文献类型 | 新闻 |
条目标识符 | http://119.78.100.173/C666/handle/2XK7JSWQ/299898 |
专题 | 气候变化 资源环境科学 |
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