业界动态监管公开信息 · WHO

随着治疗研究的推进,两种新候选疫苗将加入埃博拉试验

WHO News · 2026-11-04 08:00

正文 · 中文译文

世界卫生组织(WHO)召集的专家组建议将两种新的埃博拉候选疫苗纳入刚果民主共和国(DRC)正在进行的Tumaini临床试验。该建议标志着首次在疾病暴发期间评估专门设计用于预防本迪布焦型病毒(导致当前暴发的病毒)的疫苗。 两种候选疫苗分别是牛津大学与印度血清研究所合作开发的ChAdOx1和Moderna公司的mRNA-1469。WHO的独立候选疫苗优先排序技术咨询组本周基于现有临床前和早期临床证据建议对两者进行进一步临床评估。两家公司于周一被告知。候选疫苗将在获得国家批准后进入试验。 “这些疫苗已准备好进入临床试验,这证明了科学和合作的力量,”WHO总干事谭德塞博士说。“我感谢刚果民主共和国及世界各地的科学家、卫生工作者和合作伙伴将我们带到这一步,尤其感谢参与试验的人们。他们的参与将产生可能有助于拯救生命的重要证据。仅靠疫苗无法结束这次暴发,但它们可能成为控制疫情的强大新工具。” 刚果民主共和国国家公共卫生与生物医学研究机构——国家生物医学研究所正在牵头开展该疫苗试验,并得到比利时安特卫普大学、世界卫生组织、Epicentre、无国界医生、安特卫普热带医学研究所及非洲疾病预防控制中心的支持。候选疫苗的快速研发得益于流行病防范创新联盟的投入。 Tumaini试验旨在通过单一项试验评估多种候选疫苗,采用环形疫苗接种策略,纳入确诊本迪布焦型埃博拉病毒病患者的接触者。该试验借鉴了世界卫生组织及合作伙伴十年前在西非埃博拉疫情期间开创的方法,当时在几内亚开展的一项里程碑式试验确立了Ervebo对埃博拉病毒(又称扎伊尔型埃博拉病毒)的效力。Ervebo是Tumaini试验中首个被评估的疫苗,现用于评估其对本迪布焦型埃博拉病毒的效力。 目前已建立四个疫苗接种环,另有数个正在筹备中。这些环涵盖因埃博拉患病或死亡者的接触者。 对潜在治疗方法的研究也在推进。世界卫生组织(WHO)资助的PARTNERS试验于7月启动,正在评估单克隆抗体MBP134、抗病毒药物瑞德西韦或两者联合使用能否提高确诊本迪布焦病毒病患者的生存率。此外,maftivimab即将被纳入该试验,以评估其作为潜在治疗方法的用途。一项使用obeldevisir的补充性暴露后预防研究正在进行中。 WHO正通过其研发蓝图和卫生紧急项目在本迪布焦病毒病疫情期间支持研究,包括制定研究方案、提供战略和技术建议、协调各合作伙伴,以及提供行动支持,将严谨且符合伦理的研究纳入应对工作。 治疗试验的初步结果预计将在未来几个月内公布,疫苗试验的结果预计将于2027年初公布。 关于WHO 世界卫生组织致力于增进全人类福祉并以科学为指导,领导和倡导全球努力,让世界各地的每个人都享有获得安全健康生活的平等机会。我们是联合国卫生机构,在150多个地点连接各国、合作伙伴和人民——引领全球应对突发卫生事件,预防疾病,解决健康问题的根本原因,并扩大药品和卫生保健的可及性。我们的使命是支持所有国家促进、提供和保护健康。“携手为健康,与科学同行”是2026年世界卫生日的主题,标志着为期一年的宣传活动,旨在强调科学是保护全球健康与福祉的基础。

正文 · 英文原文

Expert groups convened by the World Health Organization (WHO) have recommended adding two new Ebola vaccine candidates to the ongoing Tumaini clinical trial in the Democratic Republic of the Congo (DRC). The recommendation marks the first time vaccines specifically designed to protect against Bundibugyo virus, the virus responsible for the current outbreak, will be evaluated during an outbreak of the disease. The two vaccine candidates are ChAdOx1, developed by the University of Oxford with the Serum Institute of India, and Moderna’s mRNA-1469. WHO’s independent Technical Advisory Group on Candidate Vaccine Prioritization recommended both for further clinical evaluation this week, based on available preclinical and early clinical evidence. The companies were informed on Monday. The vaccine candidates will enter the trial following national approvals. “The fact that these vaccines are ready to enter clinical trials is a testament to the power of science and partnership,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “I thank the scientists, health workers and partners in the DRC and around the world who have brought us to this point, and especially the people taking part in the trial. Their participation will generate vital evidence that could help save lives. Vaccines alone will not end this outbreak, but they could become a powerful new tool for bringing it under control.” The Institut National de Recherche Biomédicale, the DRC's national public health and biomedical research institute is leading the vaccines trial, with support from the University of Antwerp, Belgium, WHO, Epicentre, Médecins Sans Frontières, the Institute of Tropical Medicine of Antwerp, and the Africa Centres for Disease Control and Prevention. The rapid development of candidate vaccines is made possible by investments by the Coalition for Epidemic Preparedness Innovations. Tumaini is designed to test multiple vaccine candidates within a single trial, using a ring-vaccination approach that enrolls contacts of people with confirmed Bundibugyo virus disease. It builds on an approach pioneered by WHO and partners during the West Africa Ebola outbreak a decade ago, when a landmark trial in Guinea established the efficacy of Ervebo against Ebola virus, also known as Zaire ebolavirus. Ervebo is the first vaccine being evaluated in a Tumaini trial to now assess efficacy against Bundibugyo virus. Four vaccination rings are already in place, with several more being prepared. The rings include contacts of people who became ill or died from Ebola. Research into potential treatments is also advancing. The WHO-sponsored PARTNERS trial, launched in July, is evaluating whether the monoclonal antibody MBP134, the antiviral remdesivir, or a combination of both can improve survival among patients with confirmed Bundibugyo virus disease. In addition, maftivimab will soon be added to the trial to assess its use as a potential treatment. A complementary post-exposure prophylaxis study with obeldevisir is underway. WHO is supporting research during the Bundibugyo virus disease outbreak through its R&D Blueprint and Health Emergencies Programme, including developing research protocols, providing strategic and technical advice, coordinating among partners, and providing operational support to embed rigorous and ethical studies within the response. Initial findings from the treatment trials are expected in the coming months, with results from the vaccine trial expected in early 2027. About WHO Dedicated to the well-being of all people and guided by science, WHO leads and champions global efforts to give everyone, everywhere, an equal chance at a safe and healthy life. We are the United Nations’ agency for health that connects nations, partners and people in more than 150 locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health issues and expanding access to medicines and health care. Our mission is to support all countries to promote, provide and protect health. “Together for health. Stand with science”, the theme of World Health Day 2026, marks a year-long campaign to highlight science as the foundation for protecting health and well-being worldwide.

English
Two new candidate vaccines to join Ebola trial as treatment research advances
内容仅供参考,不构成诊疗建议,不能替代执业医师的诊断。

← 返回元界