Kaiser Washington Vaccine and Treatment Evaluation Unit

凯撒华盛顿疫苗和治疗评估单位

基本信息

批准号：
10397719
负责人：
LISA A JACKSON
金额：
$ 33.75万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-11 至 2022-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10397719
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 infection 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

项目摘要

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，许多类型的感染已影响深远的全球性后果。开发疫苗、治疗方法、设备和诊断方法的能力预防、治疗和识别传染病是一项重要的公共卫生需求。临床试验是一个不可或缺的组成部分这些开发工作的组成部分。自 20 世纪 60 年代以来，疫苗和治疗评估单位（VTEU）已经进行了一些试验，评估了有希望的传染病疫苗和候选治疗药物流感（包括大流行性流感和禽流感）、疟疾、结核病、肺炎球菌等疾病感染，儿童和成人。此外，VTEU 已针对新的情况迅速启动了试验。新出现和重新出现的传染病，例如 2009 年 H1N1 流感大流行以及第一波和第二波中国第5起H7N9禽流感疫情。这些努力提供了为公共卫生提供信息的数据政策。该提案是对新的 VTEU 结构的回应，该结构将涉及 VTEU 之间更大的合作 VTEU、NIAID 和新成立的领导小组结构都是 NIAID 传染病的一部分疾病临床研究联盟 (IDCRC)。 IDCRC将加强整合和效率运营，重要的是，将促进协作团队科学方法现在被认为是最佳的解决重要而复杂的公共卫生研究重点。根据新的合作协议，Kaiser Washington VTEU将继续开展临床研究和试验，包括在凯撒华盛顿综合护理系统内根据 IND 或 IDE 进行的试验为 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，包括人体挑战模型，和药代动力学研究。该研究将与西雅图地区传染病部门合作进行疾病研究合作伙伴将提供科学专业知识、专业设施和先进的免疫实验室能力。凯撒华盛顿 VTEU 也将发展和维持激增临床现场、药房和实验室操作的能力，以便能够快速启动临床试验和针对新出现和重新出现的对公共卫生具有重要意义的传染病威胁的其他研究。