
日内瓦 —— 世界卫生组织总干事表示,针对刚果民主共和国当前埃博拉疫情的首个疫苗临床试验于10月23日开始。
GENEVA – The first clinical trial of an Ebola vaccine in the outbreak gripping the Democratic Republic of Congo began in Oct 23, the head of the World Health Organization said.
刚果民主共和国历史上最严重的埃博拉疫情病例已超过9700例,死亡人数超过4600人。
The DR Congo’s worst Ebola outbreak has passed the 9,700-case mark, with the number of deaths exceeding 4,600.
应对工作面临的诸多挑战之一,是针对引发此次疫情的本迪布焦种埃博拉病毒,目前尚无任何获批的疫苗或治疗方法。
Among the many challenges facing the response is the lack of any approved vaccines or treatments for the Bundibugyo species of Ebola behind the epidemic.
针对更常见的扎伊尔株埃博拉病毒获批使用的厄尔维博疫苗,将在刚果民主共和国进行全面人体试验,以查明其是否能对本迪布焦株提供交叉保护。
Ervebo, a vaccine approved for use against the more common Zaire strain of Ebola, will be put through a full-scale human trial in the DR Congo to see if it offers any cross-protection against Bundibugyo.
试验在刚果民主共和国东北部伊图里省首府布尼亚启动,首剂厄尔维博疫苗已在那里接种。布尼亚是此次疫情的中心。
The trial began with the first shot of Ervebo being administered in Bunia, the capital of the DR Congo’s north-eastern Ituri province, which is the epicentre of the outbreak.
“科学给我们带来希望。今天,在刚果民主共和国布尼亚,首批受试者在一项名为‘Tumaini’的新埃博拉疫苗试验中接种了疫苗,‘Tumaini’在斯瓦希里语中意为‘希望’,”世卫组织总干事谭德塞说。“这项试验将帮助我们了解,针对本迪布焦病毒设计的任何疫苗候选物是否有效,”他补充道,与此同时,现有的厄尔维博疫苗也将接受测试。
“Science gives us hope. Today, in Bunia DRC, the first participants were vaccinated in a new Ebola vaccine trial called Tumaini, which means ‘hope’ in Swahili,” WHO chief Tedros Adhanom Ghebreyesus said on“This trial will help us understand whether any of the vaccine candidates designed for Bundibugyo virus work,” he said, adding that in the meantime, the existing Ervebo vaccine would be tested.
“世卫组织正在支持这项由刚果民主共和国主导的寻找答案、挽救生命的努力。”两款在研疫苗所谓的“Tumaini”试验是一个单一试验框架,可测试多款疫苗的安全性、有效性和免疫原性。
“WHO is supporting this DRC-led effort to find answers and save lives.”Two vaccines in the pipeline The so-called Tumaini trial is a single trial framework that can test the safety, efficacy and immunogenicity of multiple vaccines.
该试验将采用环形疫苗接种策略:为被认定为感染高风险的接触者接种疫苗。
The trial will use a ring vaccination approach: immunising contacts deemed to be at high risk of infection.
该试验正准备纳入两款针对本迪布焦株的候选疫苗,这两款疫苗目前正在通过更早阶段、规模更小的临床试验。
It is gearing up to incorporate two Bundibugyo-specific candidate vaccines, which are currently advancing through earlier-stage, smaller-scale clinical trials.
一款是牛津大学正在开发的ChAdOx1腺病毒载体疫苗;另一款由美国莫德纳公司开发,采用mRNA技术。
One is a ChAdOx1 adenoviral vector jab being developed by the University of Oxford; the other, by the US-based Moderna group, uses mRNA technology.
这两款疫苗均已获得流行病防范创新联盟(CEPI)的资助,预计将“很快”进入试验阶段,CEPI在一份声明中表示。
Both have received funding from the Coalition for Epidemic Preparedness Innovations, and are expected to enter the trial “shortly”, CEPI said in a statement.
CEPI表示:“Tumaini将与受影响社区、卫生当局和疫情应对合作伙伴密切合作,产出关于疫苗性能的可靠证据,这有助于遏制疫情、挽救生命,并加强对未来邦迪布焦疫情的防范准备。”
“Tumaini will work closely with affected communities, health authorities and outbreak response partners to generate robust evidence on vaccine performance that could contribute to curtailing the epidemic, saving lives, and strengthening preparedness for future Bundibugyo outbreaks,” said CEPI.
该试验将纳入孕妇和12岁及以上儿童,为临床试验中常被排除的人群生成证据。“重要一步”世卫组织紧急项目主任奇克韦·伊赫克韦阿祖表示,该试验旨在产出严谨证据,以确定参与试验的疫苗是否能保护高危人群。
The trial will include pregnant women and children aged 12 years and older, generating evidence for populations that are often excluded from clinical trials. ‘Important step’WHO emergencies director Chikwe Ihekweazu said the trial was set up to generate the rigorous evidence needed to determine whether the participating vaccines could protect people at risk.
他说:“如果成功,这将是我们首次获得针对邦迪布焦病毒的疫苗功效明确证据——这是一项重大进展,可能改变我们应对这一疫情、为未来疫情做准备以及挽救生命的方式。”
“If successful, this would be the first time we have clear evidence of vaccine efficacy against Bundibugyo virus – a major advance that could transform how we respond to this outbreak and prepare for future outbreaks and help save lives,” he said.
埃博拉病毒通过接触体液传播并引起出血热,在过去50年里已在非洲造成超过1.5万人死亡。
Ebola, which spreads through contact with bodily fluids and causes a haemorrhagic fever, has killed more than 15,000 people in Africa over the past 50 years.
刚果(金)埃博拉疫情应对事件经理史蒂夫·阿胡卡-蒙德克表示:“将这一试验纳入埃博拉疫情应对工作,是满足受影响社区紧迫需求的重要一步。”
“Bringing this trial into the Ebola response is an important step towards addressing the urgent needs of affected communities,” said Steve Ahuka-Mundeke, the DR Congo Ebola response incident manager.
刚果(金)于5月15日宣布爆发第17轮埃博拉疫情,世卫组织两天后启动“国际关注的突发公共卫生事件”机制,这是其第二高警戒级别。
The DRC declared its 17th outbreak of Ebola on May 15, and the WHO two days later triggered a public health emergency of international concern, its second-highest alert level.