GSK埃博拉病毒疫苗将在几周内开始临床试验

GSK埃博拉病毒疫苗将在几周内开始临床试验

                               
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发布日期：2014-08-28  来源：reuters  
据熟悉情况的人士称，葛兰素史克(GSK.L)生产的埃博拉病毒疫苗将在几周内开始临床试验，美国卫生官员将在周四宣布这一消息。

                               
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消息人士称，美国国立卫生研究院(National Institutes of Health/NIH)下属的过敏与感染研究所(National Institute of Allergy and Infectious Diseases)将宣布此事。

此外，由NIH及美国国防部多名高级官员组成的指导委员会上周批准了使用三家高级实验室生产埃博拉疫苗并开展治疗的第一步计划。该消息来自熟悉计划的消息人士。

这三家实验室分别位于德克萨斯、马里兰及北卡罗来纳，由美国卫生和公共服务部(U.S. Department of Health and HumanServices)与私人企业合作于2012年设立，旨在应对流行疾病或化学、生物、放射及核威胁。可行性分析报告将决定三家实验室中的哪一家具备生产埃博拉疫苗的能力。

疫苗实验将在美国招募健康志愿者，以测试疫苗是否安全，以及能否引发保护性免疫反应。

葛兰素史克生产的疫苗中含有一种常见的感冒病毒--腺病毒，其中被改造携带了两组埃博拉病毒的基因。动物实验显示，当细胞感染腺病毒时，埃博拉病毒基因会产生无害蛋白，刺激免疫系统产生埃博拉病毒的抗体。

葛兰素史克发言人确认了这一消息，但拒绝透露实验具体何时开始。

Clinical trial to start soon on GSK Ebola vaccine

LONDON, Aug 10 (Reuters) - A clinical trial of an experimental vaccine against the deadly Ebola virus is set to start shortly, according to British drugmaker GlaxoSmithKline , which is co-developing the product with U.S. scientists.

The world's worst outbreak of Ebola has killed nearly 1,000 people in West Africa and the disease could continue spreading for months, increasing pressure on researchers to accelerate their work on new medical interventions.

There is no proven cure or vaccine to prevent infection with Ebola and the scale of the current outbreak has prompted the World Health Organisation to declare it an international health emergency.

GSK's experimental vaccine has already produced promising results in animal studies involving primates and it is now due to enter initial Phase I testing in humans, pending approval from the U.S. Food and Drug Administration.

A company spokeswoman said on Sunday that the trial should get underway "later this year", while GSK's partner the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement on its website it would start "as early as fall 2014", implying a potential September launch of testing.

Even if is fast-tracked, however, and emergency procedures are put in place, the new vaccine could not be ready for widespread deployment before 2015 - even assuming it works as well as hoped.

"It is right at the beginning of the development journey and still has a very long way to go," the GSK official said, declining to be drawn on a possible timeline for launch.

The investigational vaccine is based on a chimpanzee adenovirus into which two Ebola genes have been inserted, which means it contains no infectious Ebola virus material. Adenoviruses are best known for causing the common cold.

once the vaccine enters a cell and delivers its genetic payload, the two gene inserts produce a protein that generates an immune response in the body - but the adenovirus carrying the genes does not replicate further.

GSK acquired the vaccine after buying Swiss-based biotech company Okairos for 250 million euros ($335 million) last year.

The U.S. NIAID - part of the National Institutes of Health - is also supporting work on other early-stage Ebola vaccines, including one from Johnson & Johnson's Crucell unit that should enter Phase I clinical testing in late 2015 or early 2016.

The Crucell vaccine is designed to give additional protection against Marburg, another severe and highly fatal disease caused by a virus from the same family as Ebola. ($1 = 0.7458 Euros) (Editing by Keiron Henderson)

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