At the time of writing in 2019, there have been 754 confirmed cases of Lassa fever in Nigeria, 21% of whom have died. Lassa is on the priority pathogen list for WHO's R&D Blueprint for Action to Prevent Epidemics. In September 2019, WHO convened 67 scientists, regulators, ethicists, public health officials, funders and vaccine developers to discuss the end-to-end clinical development plan for Lassa fever vaccines. The substantial increases in vaccine trial capacity in Africa were reviewed, together with lessons learned from the evaluation of vaccines against HIV, TB, malaria, and Ebola in Africa. Participants agreed on a pathway for Lassa vaccine trial progression, as outlined in WHO's Lassa fever R&D roadmap and the WHO Lassa fever Target Product Profile. Two Phase 1 trials of Lassa vaccines have already started, and it was agreed that continuing interactions between high income and African regulatory and ethics authorities and WHO will be important in progression towards Phase 2b/3 efficacy trials in Lassa fever endemic areas. There was agreement that, for diseases whose burden is mainly in Africa, it should be the norm that African regulatory authorities are consulted on trial design/progression before first-in-human Phase 1 trials. Phase 2b-3 vaccine trial capacity needs to be in place in high Lassa fever burden areas where efficacy trials will take place. Licensure of one or more Lassa fever vaccines suitable for West African populations is a realistic goal in the next 5 years, with CEPI and WHO aligned on the pathway forward for vaccine development.

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会议报告：2019年9月10日至11日在达喀尔举行的世卫组织关于加快流行国家拉沙热疫苗开发的磋商会。

在撰写本文时，尼日利亚已确认754例拉沙热病例，其中21％死亡。拉萨（Lassa）在世卫组织预防流行病研发蓝图的优先病原体名单中。2019年9月，世卫组织召集67位科学家，监管者，伦理学家，公共卫生官员，资助者和疫苗开发人员讨论拉萨热疫苗的端到端临床开发计划。审查了非洲疫苗试验能力的大幅提高，以及从评估针对非洲的HIV，TB，疟疾和埃博拉疫苗的经验教训。与会者同意了世卫组织拉萨热研发路线图和世卫组织拉萨热目标产品简介中概述的拉萨疫苗试验进展的途径。拉萨疫苗的两项1期试验已经开始，并商定，高收入与非洲监管和道德当局以及世卫组织之间的持续互动对于在拉萨热流行地区进行2b / 3期疗效试验的过程中将是重要的。已经达成共识，对于负担主要在非洲的疾病，应该在人类首次进行1期临床试验之前就试验设计/进行咨询非洲监管机构的规范。需要在将进行功效试验的高拉萨热负担地区建立2b-3期疫苗试验能力。在未来5年中，为CEPI和WHO调整疫苗开发的前进方向，对一种或多种适用于西非人群的Lassa发烧疫苗进行许可是一个现实的目标。