
据无国界医生组织(Médecins Sans Frontières)消息,首名受试者已在一项临床试验中接种疫苗,该疫苗有望预防刚果民主共和国(DRC)埃博拉疫情背后的病毒株。
The first person has been inoculated in a clinical trial for a vaccine that could help protect against the viral strain behind the Ebola outbreak in the Democratic Republic of the Congo (DRC), according to Médecins Sans Frontières (Doctors Without Borders).
世界卫生组织非洲区域办事处周二发布消息称,邦迪布焦埃博拉病毒(BDBV)是一种罕见的埃博拉变体,是导致刚果(金)疫情的病原,该疫情已造成逾1万例病例、近5000人死亡。目前尚无疫苗或治疗手段可用于治疗邦迪布焦病毒。
Bundibugyo ebolavirus (BDBV), a rare variant of Ebola, is behind the DRC outbreak that has led to more than 10,000 cases and nearly 5,000 deaths, the World Health Organization Regional Office for Africa posted Tuesday. There are no currently no vaccines or treatments available to treat Bundibugyo virus.
这项名为“Tumaini”的临床试验正在评估多款疫苗候选物的安全性、有效性和免疫原性——即产生免疫反应的能力。
The Tumaini clinical trial, as it's known, is evaluating the safety, efficacy and immunogenicity -- meaning the ability to generate an immune response -- of several vaccine candidates.
该试验由刚果(金)国家生物医学研究院(Institut National de Recherche Biomédicale)与比利时安特卫普大学全球健康研究所(Global Health Institute)共同资助并共同牵头。合作伙伴包括刚果卫生部、无国界医生组织(MSF)、流行病防范创新联盟(CEPI)、非洲疾病预防控制中心、世界卫生组织以及安特卫普热带医学研究所。
The trial is being co-sponsored and co-led by the Institut National de Recherche Biomédicale in the DRC and the University of Antwerp's Global Health Institute in Belgium. Partners include the Congo Ministry of Health, Médecins Sans Frontières (MSF), the Coalition for Epidemic Preparedness Innovations (CEPI), Africa Centres for Disease Control and Prevention, the World Health Organization, and the Institute of Tropical Medicine in Antwerp.
根据美国国立卫生研究院网站发布的临床试验摘要,受试者为入组前21天内曾与新确诊的邦迪布焦病毒病患者有过接触的人员。
Participants are made up of people who at the time of enrollment were contacts within the previous 21 days of a patient who is a newly confirmed case of Bundibugyo virus disease, according to a summary of the clinical trial posted on the National Institutes of Health website.

根据临床试验摘要,试验第1天,受试者随机分配接种BDBV疫苗候选物或接受标准治疗。第29天,所有受试者接受另一种干预措施,以便每位受试者都有机会接种候选疫苗,同时保持组间比较的盲法状态。
On day 1 of the trial, participants are randomized to receive either a BDBV vaccine candidate or standard treatment, according to the clinical trial summary. On day 29, all participants receive the alternative intervention so that every participant is offered a candidate vaccine while allowing the comparison between groups to remain blinded.
一个独立的数据监测委员会将审查试验期间积累的数据,同时将更多疫苗候选物纳入评估,并停止评估那些被证明无效的候选物。
An independent data monitoring committee will review data accumulated during the trial while additional vaccine candidates are added to the evaluation and others are discontinued if they are shown to be ineffective.
该总结指出:“总体目标是产生可靠证据,以支持在疫情应对和未来流行病防备中使用 BDBV 疫苗。”
"The overall aim is to generate robust evidence to support the use of BDBV vaccines for outbreak response and future epidemic preparedness," the summary states.
无国界医生组织周一表示,首个被研究的疫苗候选物是 ERVEBO,该疫苗经开发并获许可,用于预防扎伊尔埃博拉病毒,这是最致命的埃博拉病毒株。
MSF said Monday that the first vaccine candidate being studied is ERVEBO, which was developed and licensed to protect against the Zaire ebolavirus, which is the deadliest Ebola strain.
据无国界医生组织称,至少两种针对邦迪布焦病毒的疫苗候选物将接受测试,分别由 Moderna 公司和牛津大学与印度血清研究所合作开发,并由流行病防范创新联盟(CEPI)提供资助。无国界医生组织还表示,“Tumaini”试验将特别纳入儿童。
At least two Bundibugyo-specific vaccine candidates being developed by Moderna and the University of Oxford in collaboration with the Serum Institute of India, and funded by CEPI, will be tested, according to MSF, which also said the Tumaini trial will notably include children.
无国界医生组织研究部门 Epicentre 负责人瓦莱丽·布里昂表示:“在某些地区,儿童是埃博拉疫情中受害最严重的群体之一,但他们在临床研究中历来代表性不足。纳入孕妇和 12 岁及以上儿童,以及针对 ERVEBO 疫苗纳入 1 岁及以上儿童,是为那些常被排除在临床试验之外的人群生成证据迈出的重要一步。”
"Children are among those hardest hit by the Ebola outbreak in certain regions, yet they have historically been underrepresented in clinical research," said Valérie Briand, head of MSF's research division, Epicentre. "The inclusion of pregnant women and children aged 12 years and older, as well as children from one year of age for the ERVEBO vaccine, represents an important step toward generating evidence for populations that are often excluded from clinical trials."