A Thermostable Measles Vaccine

描述（由申请人提供）：麻疹仍然是全球排名第一的公共卫生疾病，每年有50万或更多的死亡病例和数百万病例。根除麻疹的主要障碍被认为是缺乏热稳定的疫苗。在这份修订申请中，我们建议开发一种耐热性麻疹疫苗。我们的团队已经开发、测试并实施了一种耐热牛瘟疫苗。麻疹与牛瘟密切相关，因此我们相信我们应该能够将牛瘟模型应用于麻疹。小组成员包括印度血清研究所，该研究所生产的麻疹疫苗比世界上任何国家都多（每年4亿剂）。顾问包括疾病预防控制中心的麻疹实验室，被公认为世界上首屈一指的麻疹基因组实验室之一。在这次重新申请中，我们将重点放在麻疹疫苗本身的开发上，使用公认的辅料。在与世卫组织和其他方面的磋商中，我们了解到，如果我们的方法取得成功，它将被视为现有产品的重新配方，因为我们使用的是公认的赋形剂。这很可能意味着不需要进行人体测试，特别是如果我们能够证明我们的产品与目前批准并广泛销售的印度血清研究所产品在基因上是相同的。这方面的改进包括：(1)与印度血清研究所进行更明确的合作，由疫苗生产主任Rajeev Dhere博士担任研究员；(2)更明确的假设驱动实验部分；(3)添加了更多新颖的辅料方法，并进行了冷冻干燥工艺。我们增加了大量的实验细节、额外的初步数据，并确定了开发疫苗的新方法。这个项目与公共卫生有什么关系？每年有50万人死于麻疹，其中大多数是儿童。疫苗运动未能消灭麻疹，因为疫苗加热后会变质。我们的项目是制造一种新疫苗，即使没有冷藏也不会失去保护人们的能力。

DESCRIPTION (provided by applicant): Measles remains a top-rank public health disease globally, with ~500,000 or more deaths annually and many more millions of cases. The major impediment to measles eradication is believed to be the lack of an heat- stable (thermostable) vaccine. In this revised application, we proposed to develop a thermostable measles vaccine. Our team has already developed, tested, and implemented a thermostable rinderpest vaccine. Measles is closely related to rinderpest, and so we believe that we should be able to adapt the rinderpest model to measles. Team members include the Serum Institute of India, which manufactures more measles vaccine than anyone in the world (> 400,000,000 doses annually). Consultants include the Measles Laboratory of the CDC, acknowledged to be one of the premier measles genomic labs in the world. In this re-application, we focus our efforts on the development of the measles vaccine itself using accepted excipients. In consultations with WHO and others, we have learned that if our approach is successful, it will be viewed as a reformulation of an existing product since we use accepted excipients. This very likely mean that no human testing will be required, especially if we can demonstrate that our product is genetically identical to the currently approved, and widely distributed, Serum Institute of India product. Improvements in this application include: (1) a more explicit collaboration with the Serum Institute of India, with Dr. Rajeev Dhere, Director of Vaccine Production, an Investigator; (2) a more explicitly hypothesis- driven experimental section; and (3) the addition of more novel approaches to the excipients, and freeze- drying process. We have added substantial experimental detail, additional preliminary data, and identified new approaches to the development of the vaccine. What is the public health relevance of this project? Measles kills half a million people, mostly children every year. Vaccine campaigns have failed to eliminate measles because the vaccine goes bad when it is heated. Our project is to make a new vaccine that will not lose its ability to protect people if there is no refrigeration.