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默克&NewLink 埃博拉疫苗启动三期临床试验

2015-03-06 13:33:56 来源:生物谷

2015年3月6日讯 /生物谷BIOON/ -- 世卫组织WHO 5日宣布默克 -NewLink 共同研发的埃博拉疫苗将于3月7日在几内亚开始三期临床试验。

尽管西非的埃博拉疫情有所控制,但全球健康组织的权威WHO依然相当重视埃博拉病毒相关药物的研发,继默克埃博拉疫苗之后,GSK的疫苗也即将进行三期临床试验。“一定要确保疫苗供应充足。”WHO官员说道。

据统计,自2013年12月埃博拉疫情大爆发以来,已经有23,900名确诊或疑似病例,其中9800名不幸死亡,死亡名单上有近500名防疫工作人员。

三个最严重的国家——几内亚、利比里亚和塞拉利昂都表示愿意在本国范围内进行埃博拉疫苗的三期临床实验,利比里亚正在组织了GSK和默克疫苗的小试。塞拉利昂很快也会公布计划。

最近埃博拉新生病例锐减,验证疫苗是否真的有效变得困难。但WHO态度坚定,必须加快推进疫苗临床试验。WHO埃博拉药物研发组带头人Marie-Paule Kieny说:“现阶段不能掉以轻心,必须将埃博拉病例降到零。”“疫苗是消灭疫情最好的手段,也是未来预防疫情的重要手段。”

此次临场试验将在几内亚的Basse Guinée 地区进行大规模接种试验,类似于20世纪70年代广泛接种天花疫苗那样。与病人接触过的每个人都要进行接种。

“在疫情尚未消退之时就进行在研药物的临床试验实在很有挑战,但同时,这也是寻找一种安全有效的疫苗的最好的途径,我们希望在最短的时间内挽救更多的生命。”惠康基金会主席Jeremy Farrar如是说。惠康基金会一直奔波在埃博拉疫苗的研发和推广上。

利比里亚已经连续13天没有报道新生病例了。政府说此次临床试验会为埃博拉疫情画上耀眼的句号。据当地媒体报道,某些居民现在很排斥麻疹疫苗和脊髓灰质炎疫苗,因为谣传接种疫苗可能会感染埃博拉病毒。

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英文原文:

(Reuters) - Final stage trials of an Ebola vaccine being developed by Merck and NewLink Genetics will begin in Guinea on March 7, the World Health Organization said on Thursday.

Signaling global health authorities' determination to see through trials despite a sharp drop in cases in the West Africa epidemic, the WHO said a second shot, developed by GlaxoSmithKline will be tested "in a sequential study, as supply becomes available".

More than 23,900 confirmed and suspected cases of Ebola have been reported since the outbreak began in December 2013, including some 9,800 deaths. Nearly 500 health workers have been among the dead in what is the worst ever Ebola epidemic.

All three worst-hit countries - Guinea, Liberia and Sierra Leone - aim to conduct final-stage trials of vaccines, and Liberia is already testing the GlaxoSmithKline and Merck-NewLink shots, while Sierra Leone is expected to announce plans soon.

But recent steep declines in new Ebola cases will make it far harder to prove whether experimental vaccines work, as the vaccine's effect will be difficult to establish.

The WHO, however, said it was committed to pushing ahead.

"The Ebola epidemic shows signs of receding but we cannot let down our guard until we reach zero cases," said Marie-Paule Kieny, head of the WHO's Ebola research and development effort.

"An effective vaccine to control current flare-ups could be the game-changer to finally end this epidemic and an insurance policy for any future ones."

The trial in the Basse Guinée region, which has Guinea's most cases, will use a "ring vaccination" strategy similar to that used to eradicate smallpox in the 1970s. This involves vaccinating everyone who has been in contact with a newly diagnosed person or "index" case.

"Testing investigational medicines during an epidemic is incredibly challenging, but this approach gives us the best possible chance of finding a safe and effective vaccine in time to save lives," said Jeremy Farrar, director of Wellcome Trust, the medical charity that has led the push for Ebola vaccines.

In Liberia, where no new cases have been reported for 13 days, the government says the trial is a "resounding success".

But local media has reported that some residents are refusing measles and polio vaccinations amid rumors of a deliberate plot to infect them with Ebola.

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