中新网北京3月20日电 比尔及梅琳达·盖茨医学研究所19日发表声明宣布，启动结核病候选疫苗M72/AS01E(M72)Ⅲ期临床试验，在南非开展首批疫苗接种。
结核病是一种由结核分枝杆菌引起的古老疾病，是全球导致死亡人数最多的单一传染病。尽管有多种治疗方法和预防策略，结核病仍然在全球范围内构成重大健康威胁。盖茨医学研究所此次启动的Ⅲ期临床试验，标志着在开发新型结核病疫苗方面迈出了重要一步。
M72/AS01E是由葛兰素史克（GSK）和盖茨医学研究所合作开发的候选疫苗，它使用了一种创新的疫苗配方，旨在激发强大的免疫反应，以预防结核病。Ⅲ期临床试验将评估该疫苗在健康成年人中的安全性、免疫原性和保护效果，这也是疫苗研发过程中最关键的阶段。
南非作为首批开展疫苗接种的国家，其高结核病发病率使得它成为评估候选疫苗有效性的理想地点。临床试验将遵循严格的国际标准和指南，以确保受试者的安全和数据的可靠性。
此次临床试验不仅是全球抗击结核病努力的一部分，也体现了公私合作在推动公共卫生领域创新中的重要作用。盖茨医学研究所表示，他们将致力于与全球合作伙伴一起，加速疫苗的研发和推广，以期在全球范围内减少结核病的发病率和死亡率。
英文标题：Gates Medical Research Institute Launches Phase III Clinical Trial for TB Vaccine Candidate
英文关键词：Gates Medical Research Institute, Tuberculosis, Vaccine Candidate, Phase III Clinical Trial
英文新闻内容：
March 20, 2023, Beijing, China – The Bill & Melinda Gates Medical Research Institute (Gates MRI) announced on March 19 that it has initiated Phase III clinical trials for the tuberculosis (TB) vaccine candidate M72/AS01E (M72), with the first vaccinations taking place in South Africa.
Tuberculosis, caused by the bacterium Mycobacterium tuberculosis, remains one of the world’s deadliest infectious diseases, despite the availability of multiple treatments and prevention strategies. The Phase III trial represents a significant step forward in the development of a new TB vaccine.
M72/AS01E, a candidate vaccine developed in collaboration with GlaxoSmithKline (GSK) and Gates MRI, employs an innovative vaccine formulation designed to elicit a strong immune response against TB. The Phase III trial will evaluate the safety, immunogenicity, and efficacy of the vaccine in healthy adults, which is the critical phase in vaccine development.
South Africa, with one of the highest TB burdens globally, is an ideal location to assess the candidate vaccine’s efficacy. The clinical trial will adhere to stringent international standards and guidelines to ensure the safety of participants and the reliability of the data.
This trial is part of the global effort to combat TB and highlights the critical role of public-private partnerships in driving innovation in public health. Gates MRI has committed to working with global partners to accelerate vaccine development and deployment, aiming to reduce the global incidence and mortality rates of TB.
【来源】http://www.chinanews.com/gj/2024/03-20/10183529.shtml
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