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GSK埃博拉疫苗即将进入三期临床研究!

2015-01-26 17:46:07 来源:生物谷

2015年1月25日讯 /生物谷BIOON/ --制药巨头葛兰素史克公司最近宣布,公司开发的首批埃博拉疫苗即将进入临床三期研究阶段。此次,葛兰素史克公司将生产的在研疫苗运输至利比里亚,并将在当地招募志愿者已进行相关研究。据悉,这一研究也是美国国家健康中心(NIH)支援西非对抗埃博拉疫情的一部分。NIH计划在当地招募约3万名患者进行相关研究,其中三分之一将接受葛兰素史克公司的疫苗产品,以判断其有效性。根据葛兰素史克公司疫苗研发部门主管Moncef Slaoui的介绍,这种埃博拉疫苗产品在临床一期研究中表现出了良好的免疫反应和安全性。如果临床三期研究中能够获得理想效果,将对今后防止埃博拉病毒的蔓延起到重大作用。

根据世界卫生组织的报告,2014年爆发在西非的埃博拉疫情目前已经得到了一定的控制,最近几个月埃博拉病毒的传播变得缓慢下来。但是,WHO官员仍然提醒说,目前还没有到松懈下来的时候。相关数据显示,自疫情爆发以来,已经发现有超过两万例埃博拉病例,其中近9000名患者死亡。这其中还包括了许多的医护人员。

而此次疫情爆发之后,埃博拉疫苗也已经成为了各大生物医药公司的一个重大课题。不久前,强生公司宣布,公司已经获得了欧盟下属创新药物研发中心总额高达1亿1千6百万美元的追加投资以加速其临床研究进程。目前,强生公司已经与包括牛津大学等世界各地多家医学研究机构在这一项目上建立紧密地合作关系。据了解,强生公司于本月6号正式开始该疫苗的临床一期研究,为了尽快完成相关临床研究,强生公司计划到今年四月份之前,生产超过4万份疫苗进行实验;而整个2015年,强生公司计划生产约2百万份疫苗产品以进行研究。而目前,在这一领域中走的最远的当属葛兰素史克公司。此外,强生公司等也都紧随开后开发相关疫苗。

详细英文报道:

GlaxoSmithKline ($GSK) has shipped out the first batch of its in-development Ebola vaccine, expecting to kick off late-stage studies in the coming weeks.

The shipment, containing 300 vials, is due to arrive in Liberia today, the company said, fueling a National Institutes of Health-sponsored effort to get a handful of potential treatments for the virus through Phase III development. NIH is hoping to enroll about 30,000 people in the trial, focusing on frontline healthcare workers in Ebola-affected nations. About one-third of those patients will get GSK's shot, the company said, comparing it with a control vaccine to determine its efficacy in preventing infection.

GSK's candidate, developed alongside the NIH's National Institute of Allergy and Infectious Diseases, proved itself safe and charted a promising immune response in Phase I, and Vaccines Chairman Moncef Slaoui said the company is hopeful it can deliver in Phase III.

"If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks," Slaoui said in a statement. "It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made."

Meanwhile, the WHO has said that the outbreak of Ebola in West Africa has slowed over the past few months but cautioned that there is much work to be done to contain its spread. Since Ebola broke out last year, WHO has tracked more than 20,000 reported cases and nearly 9,000 deaths.

GSK's candidate is the furthest along among Ebola vaccines in development, leading efforts from partners Merck ($MRK) and NewLink Genetics ($NLNK) and the team of Johnson & Johnson ($JNJ) and Bavarian Nordic. Separately, regulators have fast-tracked treatments from Fujifilm, Mapp Biopharmaceutical and Chimerix ($CMRX) in hopes of finding a cure for the infection.

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