Kaiser Washington VTEU supplement 20-0003

凯撒华盛顿 VTEU 补充 20-0003

• 批准号: 10202069
• 负责人: LISA A JACKSON
• 金额: $ 750.52万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-22 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10202069
• 关键词: Acute respiratory infection; Address; Adjuvant; Adult; Age; Anti-Infective Agents; Area; Avian Influenza; Biological Response Modifier Therapy; Biomedical Research; Cancer Research Network; Caring; Centers for Disease Control and Prevention (U.S.); Child; China; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Communities; Computerized Medical Record; Conduct Clinical Trials; Contracts; Data; Development; Devices; Diagnostic; Doctor of Philosophy; Drug Kinetics; Elderly; Elements; Emerging Communicable Diseases; Enrollment; Evaluation; Fostering; Group Structure; HIV Vaccine Trials Network; Health; Health Policy; Human; Immunologics; Immunology; Infection; Infectious Diseases Research; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H7N9 Subtype; Influenza prevention; Infrastructure; International; Kentucky; Laboratories; Leadership; Malaria; Malaria Vaccines; Medical center; Modeling; National Institute of Allergy and Infectious Disease; Outpatients; Persons; Pharmacy Schools; Pharmacy facility; Phase; Pneumococcal Infections; Population; Population Heterogeneity; Pregnant Women; Preventive; Protocols documentation; Public Health; Research; Research Institute; Research Personnel; Research Priority; Resources; Respiratory Tract Infections; Rhea; Schedule; Science; Seasons; Site; Structure; Therapeutic; Tuberculosis; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Washington; Work; care systems; clinical research site; design; experience; experimental study; health plan; high risk population; influenza outbreak; influenza virus vaccine; innovation; malaria infection; member; multidisciplinary; neglected tropical diseases; novel vaccines; operation; pandemic disease; pandemic influenza; pharmacokinetic model; prevent; programs; public health research; research study; response; supportive environment; therapeutic candidate; training opportunity; vaccine candidate; vaccine effectiveness; vaccine trial; working group

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.

抽象的 传染病继续对人类健康构成重大威胁，许多类型的感染有 深远的全球后果。开发疫苗，治疗学，设备和诊断的能力 预防，治疗和识别传染病是批判性的公共卫生需求。临床试验是不可或缺的 这些开发工作的组成部分。自1960年代以来，疫苗和治疗评估单位 （VTEUS）进行了试验，该试验评估了有希望的疫苗和治疗候选物 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已迅速启动了试验以应对新的 新兴和重新出现的传染病，例如2009年流感H1N1大流行，波1和波浪1和 中国的H7N9鸟类流感爆发中有5次。这些努力提供了通知公共卫生的数据 政策。 该建议是对新的VTEU结构的回应，该结构将涉及更大的合作 VTEUS，NIAID和新成立的领导小组结构都是Niaid感染力的一部分 疾病临床研究联盟（IDCRC）。 IDCRC将提高集成和效率 运营，重要的是，将促进合作团队科学方法现在被认为是最佳的 解决重要且复杂的公共卫生研究重点。 根据新的合作协议，Kaiser Washington VTEU将继续进行临床研究 和试验，包括根据IND或IDE进行的试验，在Kaiser Washington Integrated Care系统中 为NIAID的优先研究重点做出贡献。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。该研究将与西雅图地区的感染性进行 疾病研究伙伴将提供科学专业知识，专业设施和高级 免疫实验室能力。 Kaiser Washington VTEU也将发展和维持激增 临床部位，药房和实验室操作的能力，可以快速启动临床试验和 其他研究响应新兴和重新出现的传染病威胁公共卫生的重要性。