英國政府官方發布:世界首個CCP病毒受控人體感染試驗在英國獲批

五月花寫作組 | 翻譯:jiasen | 校對:傘兵 | 編輯:jamie(文胤) | 美工、發稿:滅共小宇宙

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 在獲得英國臨床試驗倫理委員會的批準後,英國將成為世界上第一個進行CCP病毒受控人體感染試驗的國家(圖片來源:ris.world

發布日期:2021年2月17日

發布者:商業、能源與工業戰略部和Rt Hon Hwasi Kwarteng議員


• 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

• 英國實現了向1500萬人提供首次疫苗註射的目標。在同一周,經倫理委員會批準,第一項CCP病毒受控人體感染試驗將在一個月內展開

• 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

• 研究人員呼籲健康的年輕人自願參加這項研究,該項研究將在研發有效的CCP病毒疫苗和治療方案中發揮關鍵作用

• 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

• 多達90位18至30歲的志願者將在安全可控的環境中暴露於病毒,以加深對病毒影響人類的機理的理解

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.

在英國政府3360萬英鎊投資的支持下,針對CCP病毒的首項此類研究將確定引起感染所需的最小病毒量,這將使醫生們對病毒有更加深入的瞭解,從而有助疫苗和治療方案的優化。

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.

此項研究將在接下來的幾周內展開,它將涉及多達90名經過仔細挑選,健康的成人志願者。他們將在安全可控的環境中接觸病毒。

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.

志願者的安全至高無上,這意味著該病毒的特性研究將首先使用2020年3月以來在英國傳播的毒株,現已證明該毒株對年輕健康的成年人風險較低。醫護人員和科學家將密切監視該病毒對志願者的影響,並提供24小時全程護理。

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.

研究人員還與皇家自由醫院和倫敦中北部成人重症監護網路密切合作,以確保該研究不會影響國民保健署在大流行期間為患者提供護理的能力。 沒有他們的批準,這項研究就不會展開。

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.

一旦初始研究展開,少量志願者可被提供已在臨床試驗中證明安全的候選疫苗,隨後他們會接觸病毒,以幫助確定最有效的疫苗並加速研發過程。

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.

研究人員鼓勵年齡在18至30歲之間的民眾自願參加這項至關重要的研究,他們面臨的由冠狀病毒引發的並發症的風險是最低的。志願者在研究中所耗費的時間會得到補償。

Business Secretary Kwasi Kwarteng said:

商業部長誇西·克騰(Kwasi Kwarteng)說:

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

世界各地的研究人員和科學家已經在瞭解CCP病毒和開發用於保護民眾的關鍵疫苗方面取得了了不起的進展。

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.

盡管疫苗開發取得了非常積極的進展,但我們希望找到最好,最有效的疫苗,以便長期使用。這些受控人體感染試驗將在英國進行,並將助力科學家瞭解CCP病毒如何影響人類,最終促進疫苗的快速研發。

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.

幾十年來,受控人體感染試驗一直在安全地進行著,並在加速開發針對瘧疾,傷寒,霍亂,諾如病毒和流感等疾病的治療方法中發揮了重要作用。這些試驗還幫​​助了研究人員確定哪種疫苗最有可能在隨後的三期臨床試驗中獲得成功,這些試驗通常涉及數千名志願者。

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.

這項初步研究還將幫助醫生瞭解免疫系統對病毒的反應,並確定影響病毒傳播的因素,包括病毒感染者如何將傳染性病毒顆粒傳播到環境中。

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.

受控人體感染試驗是由政府疫苗工作組,倫敦帝國理工大學,倫敦皇家自由國民保健基金會信托基金和業界領先的臨床公司hVIVO合作開展,該公司開創了受控人體感染模型。

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.

皇家自由醫院的專家和位於倫敦的安全臨床研究設施專門用於隔離該病毒。訓練有素的醫務人員和科學家將隨時檢查病毒在體內的狀態,並確保志願者的安全。

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.

在特徵研究中使用的病毒是由倫敦大奧蒙德街兒童醫院國民保健基金會信托基金與hVIVO合作,在倫敦帝國理工病毒學家的支持下培養的。

Interim Chair of the Vaccines Taskforce Clive Dix said:

疫苗工作組臨時主席克萊夫·迪克斯(Clive Dix)說:

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.

我們已經為英國設法獲得了許多安全有效的疫苗,但是至關重要的是,我們要繼續研發新的疫苗和治療方法。我們希望這些研究能夠為病毒的工作原理提供獨到的見解,並幫助我們瞭解哪些有前景的疫苗可以最好地預防感染。

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

倫敦帝國理工大學首席研究員克裡斯·邱(Chris Chiu)博士說:

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.

我們希望18至30歲的志願者加入這項研究工作,幫助我們瞭解該病毒如何感染人類以及病毒如何在人際間成功傳播。我們最終的目標是確定哪些疫苗和治療方法可以最好地戰勝這種疾病,但我們需要志願者來支持這項工作。

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said:

hVIVO的首席科學官安德魯·卡奇波爾(Andrew Catchpole )博士說:

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.

對臨床研究計劃的倫理審查是進行臨床研究的關鍵部分,倫理委員的批準是CCP病毒感染模型研發中非常重要的里程碑。CCP病毒受控人體感染試驗可能會在提供數據和信息方面發揮重要作用,這將有助於繼續研發疫苗來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.

這是一項關鍵的研究,能夠建立CCP感染模型並確定所需的最低病毒致病劑量。研究得到的數據將會迅速協助病毒感染模型,用於疫苗功效測試 ,以及回答在傳統的臨床試驗中得不到的一系列基本科學問題,例如究竟需要哪種類型的免疫反應才能為人體提供保護,以防止再次被感染。


原文鏈接:

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


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