a Vaccine and Immunotherapy Center, Division of Infectious Diseases, Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.
Hum Vaccin Immunother. 2017 Dec 2;13(12):2977-2981. doi: 10.1080/21645515.2017.1371377. Epub 2017 Sep 21.
Development of vaccines that are both safe and effective remains a costly and time-consuming challenge. To accelerate the pace of development and improve the efficacy and safety of candidate vaccines for both existing and emerging infectious agents, we have used a distributed development approach. This features the managed integration of individual expert groups having the requisite vaccine platforms, pre-clinical models, assays, skills and knowledge pertinent to a specific pathogen into a single, end-to-end development team capable of producing a new vaccine tailored to that particular agent. Distributed development focuses on integrating existing effort across multiple institutions rather than developing new capabilities or consolidating resources within an individual organization. Previously we have used the distributed development strategy to generate vaccine candidates for emerging viral diseases. Coxiella burnetii is a highly infectious and resilient bacterium and the causative agent of Q fever. Treatment for Q fever can require months of antibiotics. The current vaccine for Q-fever is only approved in Australia and requires prescreening due to the potential for severe reactogenicity in previously exposed individuals. Here we discuss Q-VaxCelerate, a distributed development consortium for the development of a new vaccine to prevent Q fever.
开发既安全又有效的疫苗仍然是一个昂贵且耗时的挑战。为了加快开发速度，并提高针对现有和新出现的传染病病原体的候选疫苗的功效和安全性，我们采用了分布式开发方法。这种方法的特点是将具有必要疫苗平台、临床前模型、检测、技能和知识的各个专家小组进行管理整合，形成一个能够针对特定病原体生产新疫苗的单一的端到端开发团队。分布式开发侧重于整合多个机构的现有工作，而不是开发新的能力或整合单个组织内的资源。此前，我们曾使用分布式开发策略来为新出现的病毒性疾病生成疫苗候选物。柯克斯体是一种高度传染性和有弹性的细菌，也是 Q 热的病原体。Q 热的治疗可能需要数月的抗生素。目前 Q 热疫苗仅在澳大利亚获得批准，由于先前暴露的个体可能会出现严重的反应原性，因此需要预先筛选。在这里，我们讨论 Q-VaxCelerate，这是一个用于开发预防 Q 热的新疫苗的分布式开发联盟。
