A Thermostable Measles Vaccine

描述（由申请人提供）：麻疹仍然是全球最重要的公共卫生疾病，每年约有50万人或更多人死亡，数百万病例。据认为，消除麻疹的主要障碍是缺乏热稳定疫苗。在这份修订后的申请中，我们提议开发一种耐热麻疹疫苗。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，因此我们认为我们应该能够将牛瘟模型适用于麻疹。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一个国家都多（每年超过4亿剂）。顾问包括疾病预防控制中心麻疹实验室，该实验室被公认为世界上最重要的麻疹基因组实验室之一。在这次重新申请中，我们将重点放在使用可接受的赋形剂开发麻疹疫苗本身上。在与世卫组织和其他方面的磋商中，我们了解到，如果我们的方法成功，它将被视为现有产品的重新配制，因为我们使用了公认的辅料。这很可能意味着不需要进行人体试验，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相同。本申请的改进包括：（1）与印度血清研究所（疫苗生产总监，研究者Rajeev Dhere博士）进行了更明确的合作;（2）更明确的假设驱动实验部分;（3）在辅料和冻干工艺中添加了更多新方法。我们增加了大量的实验细节，额外的初步数据，并确定了疫苗开发的新方法。该项目与公共卫生有何相关性？麻疹每年夺去50万人的生命，其中大部分是儿童。疫苗接种运动未能消除麻疹，因为疫苗在加热时会变质。我们的项目是制造一种新的疫苗，即使没有冷藏，也不会失去保护人类的能力。

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.