英国政府官方发布:世界首个CCP病毒受控人体感染试验在英国获批

五月花写作组 | 翻译:jiasen | 校对:伞兵 | 编辑:jamie(文胤) | 美工、发稿:灭共小宇宙

The UK will be the first country in the world to run a Covid-19 human challenge study, following approval from the UK’s clinical trials ethics body 在获得英国临床试验伦理委员会的批准后,英国将成为世界上第一个进行CCP病毒受控人体感染试验的国家(图片来源:ris.world

发布日期:2021年2月17日

发布者:商业、能源与工业战略部和Rt Hon Hwasi Kwarteng议员


• First Covid-19 human challenge study will begin within a month, after receiving ethics approval in the same week the UK hits target of offering first dose to 15 million people

• 英国实现了向1500万人提供首次疫苗注射的目标。在同一周,经伦理委员会批准,第一项CCP病毒受控人体感染试验将在一个月内展开

• Researchers call on healthy young people to volunteer for the study, which will play a key role in developing effective Covid-19 vaccines and treatments

• 研究人员呼吁健康的年轻人自愿参加这项研究,该项研究将在研发有效的CCP病毒疫苗和治疗方案中发挥关键作用

• Up to 90 volunteers aged 18 – 30 years will be exposed to Covid-19 in a safe and controlled environment to increase understanding of how the virus affects people

• 多达90位18至30岁的志愿者将在安全可控的环境中暴露于病毒,以加深对病毒影响人类的机理的理解

Backed by a £33.6 million UK government investment, the first-of-its-kind study for this virus will involve establishing the smallest amount of virus needed to cause infection, which will give doctors greater understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.

在英国政府3360万英镑投资的支持下,针对CCP病毒的首项此类研究将确定引起感染所需的最小病毒量,这将使医生们对病毒有更加深入的了解,从而有助疫苗和治疗方案的优化。

Due to begin in the next few weeks, it will involve up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment.

此项研究将在接下来的几周内展开,它将涉及多达90名经过仔细挑选,健康的成人志愿者。他们将在安全可控的环境中接触病毒。

The safety of volunteers is paramount, which means this virus characterisation study will initially use the version of the virus that has been circulating in the UK since March 2020 and has been shown to be of low risk in young healthy adults. Medics and scientists will closely monitor the effect of the virus on volunteers and will be on hand to look after them 24 hours a day.

志愿者的安全至高无上,这意味着该病毒的特性研究将首先使用2020年3月以来在英国传播的毒株,现已证明该毒株对年轻健康的成年人风险较低。医护人员和科学家将密切监视该病毒对志愿者的影响,并提供24小时全程护理。

The researchers are also working very closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact on the NHS’ ability to care for patients during the pandemic. The study will not begin without their go-ahead.

研究人员还与皇家自由医院和伦敦中北部成人重症监护网络密切合作,以确保该研究不会影响国民保健署在大流行期间为患者提供护理的能力。 没有他们的批准,这项研究就不会展开。

Once this initial study has taken place, vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to the Covid-19 virus, helping to identify the most effective vaccines and accelerate their development.

一旦初始研究展开,少量志愿者可被提供已在临床试验中证明安全的候选疫苗,随后他们会接触病毒,以帮助确定最有效的疫苗并加速研发过程。

Researchers are encouraging people aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, to volunteer for this vital study. Volunteers will be compensated for the time they spend in the study.

研究人员鼓励年龄在18至30岁之间的民众自愿参加这项至关重要的研究,他们面临的由冠状病毒引发的并发症的风险是最低的。志愿者在研究中所耗费的时间会得到补偿。

Business Secretary Kwasi Kwarteng said:

商业部长夸西·克腾(Kwasi Kwarteng)说:

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

世界各地的研究人员和科学家已经在了解CCP病毒和开发用于保护民众的关键疫苗方面取得了了不起的进展。

While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term. These human challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines.

尽管疫苗开发取得了非常积极的进展,但我们希望找到最好,最有效的疫苗,以便长期使用。这些受控人体感染试验将在英国进行,并将助力科学家了解CCP病毒如何影响人类,最终促进疫苗的快速研发。

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.

几十年来,受控人体感染试验一直在安全地进行着,并在加速开发针对疟疾,伤寒,霍乱,诺如病毒和流感等疾病的治疗方法中发挥了重要作用。这些试验还帮​​助了研究人员确定哪种疫苗最有可能在随后的三期临床试验中获得成功,这些试验通常涉及数千名志愿者。

This initial study will also help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted, including how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.

这项初步研究还将帮助医生了解免疫系统对病毒的反应,并确定影响病毒传播的因素,包括病毒感染者如何将传染性病毒颗粒传播到环境中。

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

受控人体感染试验是由政府疫苗工作组,伦敦帝国理工大学,伦敦皇家自由国民保健基金会信托基金和业界领先的临床公司hVIVO合作开展,该公司开创了受控人体感染模型。

The Royal Free Hospital’s specialist and secure clinical research facilities in London are 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 the safety of volunteers.

皇家自由医院的专家和位于伦敦的安全临床研究设施专门用于隔离该病毒。训练有素的医务人员和科学家将随时检查病毒在体内的状态,并确保志愿者的安全。

The virus being used in the characterisation study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, in collaboration with hVIVO with support from virologists at Imperial College London.

在特征研究中使用的病毒是由伦敦大奥蒙德街儿童医院国民保健基金会信托基金与hVIVO合作,在伦敦帝国理工病毒学家的支持下培养的。

Interim Chair of the Vaccines Taskforce Clive Dix said:

疫苗工作组临时主席克莱夫·迪克斯(Clive Dix)说:

We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19. We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.

我们已经为英国设法获得了许多安全有效的疫苗,但是至关重要的是,我们要继续研发新的疫苗和治疗方法。我们希望这些研究能够为病毒的工作原理提供独到的见解,并帮助我们了解哪些有前景的疫苗可以最好地预防感染。

Chief Investigator Dr Chris Chiu, from Imperial College London, said:

伦敦帝国理工大学首席研究员克里斯·邱(Chris Chiu)博士说:

We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us. Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work.

我们希望18至30岁的志愿者加入这项研究工作,帮助我们了解该病毒如何感染人类以及病毒如何在人际间成功传播。我们最终的目标是确定哪些疫苗和治疗方法可以最好地战胜这种疾病,但我们需要志愿者来支持这项工作。

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said:

hVIVO的首席科学官安德鲁·卡奇波尔(Andrew Catchpole )博士说:

Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the Covid-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.

对临床研究计划的伦理审查是进行临床研究的关键部分,伦理委员的批准是CCP病毒感染模型研发中非常重要的里程碑。CCP病毒受控人体感染试验可能会在提供数据和信息方面发挥重要作用,这将有助于继续研发疫苗来控制病毒全球大流行。

This study is a key enabling study to establish the Covid-19 challenge model and determine the lowest possible dose of virus required. Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.

这是一项关键的研究,能够建立CCP感染模型并确定所需的最低病毒致病剂量。研究得到的数据将会迅速协助病毒感染模型,用于疫苗功效测试 ,以及回答在传统的临床试验中得不到的一系列基本科学问题,例如究竟需要哪种类型的免疫反应才能为人体提供保护,以防止再次被感染。


原文链接:

World’s first coronavirus Human Challenge study receives ethics approval in the UK


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