A Thermostable Measles Vaccine

耐热麻疹疫苗

• 批准号: 7213498
• 负责人: Jeffrey K Griffiths
• 金额: $ 57.76万
• 依托单位: TUFTS UNIVERSITY BOSTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-15 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7213498
• 关键词: Amino Acids; Boston; Cells; Centers for Disease Control and Prevention (U.S.); Cessation of life; Child; Collaborations; Consultations; Data; Development; Disease; Dose; Excipients; Freeze Drying; Freezing; Genetic; Genomics; Glass; Goals; Heating; Human; India; Institutes; Laboratories; Lactalbumin; Learning; Licensure; Measles; Measles Vaccine; Measles virus; Measures; Methods; Modeling; Monitor; Preparation; Process; Public Health; Refrigeration; Research Personnel; Rinderpest; Rubber; Serum; Sucrose; Testing; Time; Transition Temperature; Vaccine Production; Vaccines; Virus; World Health Organization; cold temperature; improved; killings; member; novel strategies; novel vaccines; research study; solute; sugar; thermostability; vaccine development

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.

描述（由申请人提供）：麻疹仍然是全球最高的公共卫生疾病，每年约有50万或更多的死亡死亡，数百万病例。据信，消除麻疹的主要障碍是缺乏热稳定（热稳定）疫苗。在此修订的应用中，我们提议开发一种可热稳定的麻疹疫苗。我们的团队已经开发，测试并实施了一种热固定的RinderPest疫苗。麻疹与Rinderpest密切相关，因此我们认为我们应该能够使Rinderpest模型适应麻疹。团队成员包括印度血清研究所，该研究所的生产比世界任何人都多（每年> 4亿剂量）。顾问包括CDC的麻疹实验室，被认为是世界上主要的麻疹基因组实验室之一。在这种重新施加中，我们将精力集中在使用公认的赋形剂上的麻疹疫苗本身的开发上。在与谁和其他人的协商中，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印象，因为我们使用了接受的赋形剂。这很可能意味着不需要人类测试，尤其是如果我们可以证明我们的产品在遗传上与当前已批准的印度血清研究所相同。此应用程序的改进包括：（1）与印度血清研究所进行更明确的合作，研究人员疫苗生产总监Rajeev Dhere博士； （2）更明确的假设驱动的实验部分； （3）添加更多新颖的赋形剂方法和冷冻过程。我们添加了大量的实验细节，附加的初步数据，并确定了疫苗开发的新方法。该项目的公共卫生相关性是什么？麻疹杀死50万人，每年大多是儿童。疫苗活动未能消除麻疹，因为疫苗加热时会变质。我们的项目是制造一种新的疫苗，如果没有制冷，它将不会失去保护人们的能力。