Kaiser Washington Vaccine and Treatment Evaluation Unit

摘要 传染病继续对人类健康构成重大威胁，许多类型的感染 影响深远的全球后果。开发疫苗、疗法、设备和诊断的能力 预防、治疗和识别传染病是一项重要的公共卫生需求。临床试验是一个整体 这些发展努力的组成部分。自20世纪60年代以来，疫苗和治疗评价单位 (VTEU)已经进行了试验，评估了有希望的传染病疫苗和治疗候选药物 流感(包括大流行和禽流感)、疟疾、结核病、肺炎球菌等疾病 感染，儿童和成人。此外，VTEU已迅速启动试验，以应对新的 新出现和再次出现的传染病，如2009年H1N1流感大流行和第一波和第二波 中国暴发的H7N9禽流感疫情中有5起。这些努力提供了为公众健康提供信息的数据 政策。 这项提议是对VTEU新结构的回应，该结构将涉及 VTEU、NIAID和新成立的领导班子结构都是NIAID传染病的一部分 疾病临床研究联盟(IDCRC)国际儿童权利公约“将提高综合和效率 运营，重要的是，将促进协作的团队科学方法，现在被认为是最佳的 处理重要而复杂的公共卫生研究优先事项。 根据新的合作协议，Kaiser Washington VTEU将继续进行临床研究 以及试验，包括在凯撒华盛顿综合保健系统内在IND或IDE下进行的试验 为NIAID的优先研究重点作出贡献。这些优先领域包括疟疾、流感和其他 呼吸道感染，急性呼吸道感染，包括临床试验，包括人类挑战模型， 和药代动力学研究。这项研究将与西雅图传染病地区合作进行。 疾病研究合作伙伴，将提供科学专业知识、专门设施和先进的 免疫学实验室能力。凯撒华盛顿VTEU也将发展并保持激增 临床现场、药房和实验室运营能力，以实现快速启动临床试验和 应对新出现和再次出现的传染病对公共卫生的重要威胁的其他研究。

Abstract Infectious diseases continue to pose a significant threat to human health, with many types of infections having far-reaching, global consequences. The ability to develop vaccines, therapeutics, devices and diagnostics to prevent, treat, and identify infectious diseases is a critical public health need. Clinical trials are an integral component of these development efforts. Since the 1960s the Vaccine and Treatment Evaluation Units (VTEUs) have conducted trials that have evaluated promising vaccine and therapeutic candidates for infectious diseases such as influenza (including pandemic and avian influenza), malaria, tuberculosis, pneumococcal infection, in children and adults. In addition, the VTEUs have quickly launched trials in response to newly emerging and reemerging infectious diseases, such as the 2009 influenza H1N1 pandemic, and Waves 1 and 5 of the H7N9 avian influenza outbreaks in China. These efforts have provided data that informed public health policy. This proposal is in response to a new VTEU structure which will involve greater collaboration between the VTEUs, NIAID, and the newly formed Leadership Group structure that are all part of the NIAID Infectious Diseases Clinical Research Consortium (IDCRC). The IDCRC will enhance integration and efficiency of operations and, importantly, will foster the collaborative team science approaches now recognized as optimal to address important and complicated public health research priorities. Under the new cooperative agreement, the Kaiser Washington VTEU will continue to conduct clinical research and trials, including trials conducted under an IND or IDE, within the Kaiser Washington integrated care system to contribute to the priority research foci of NIAID. These priority areas include malaria, influenza and other respiratory infections, acute respiratory infections and include clinical trials, including human challenge models, and pharmacokinetic studies. The research will be conducted in collaboration with Seattle area infectious disease research partners who will provide scientific expertise, specialized facilities, and advanced immunologic laboratory capabilities. The Kaiser Washington VTEU will also develop and maintain surge capacity for clinical site, pharmacy and laboratory operations to enable the rapid initiation of clinical trials and other studies in response to emerging and reemerging infectious disease threats of public health importance.