University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)

疫苗和治疗评估单位（VTEU）是NIAID传染病的关键资源 临床研究联盟进行临床研究和试验，以评估疫苗，预防性生物制剂， 用于治疗和预防传染性疾病的治疗剂、诊断剂、预测标记物和装置 所有年龄和风险类别的人的疾病。VTEU网络站点必须灵活， 新出现的威胁和不断变化的NIAID优先事项。为此，罗切斯特大学VTEU（UR VTEU）将 与NIAID和VTEU领导小组（VTEU LG）合作，解决并优先考虑以下举措： 传染病，如呼吸道、肠道、性传播感染和抗生素耐药性 生物以及保持灵活性，以便在需要时将重点转向新出现的威胁。大学 罗切斯特的研究人员很幸运地拥有一个对临床研究持积极态度的社区， 城市中主要医疗保健提供者之间的合作关系， 该地区的医院、诊所和诊所。UR VTEU提供经验丰富的行政和临床 具有成功的多中心临床试验工作的良好记录。在VTEU LG的支持下， 乌拉圭回合的虚拟集装箱运输股将能够很好地制定和实施一些概念和项目， 重要的NIAID优先事项，并制定最佳做法、效率和标准作业程序， VTEU站点。UR VTEU研究者拥有成人和儿科临床研究的专业知识， 招募弱势群体参加临床试验，因此可以预期成功招募年轻人 老年人、婴儿、幼儿和青少年以及孕妇。此外，关闭 门罗县卫生部门与大学的关系提供了访问患者与 性传播疾病的研究参与。我们将提供进行1-3期临床试验的能力， 试验和药代动力学研究以及人员和临床研究地点方面的激增能力， 快速响应NIAID的紧急需求。重要的是，我们的研究人员具有进行挑战的经验 和隔离研究，并可为此类项目提供VTEU设施。我们的研究实验室专业知识将 为VTEU网络提供各种最先进的技术，以询问主机响应， 以及对许多传染病发病机理有更深入的了解 疾病具体而言，核心教师在广泛的新型免疫学检测以及 转录和微生物组分析。此外，乌拉圭自愿集装箱欧盟将提供研究机会， 初级教师的教育，以培养下一代的医生科学家。所有临床试验将遵循 NIAID/NIH要求，并符合药物临床试验质量管理规范。总之，乌拉圭的VTEU网站将提供一个 一个热情和多样化的研究小组，有参与合作研究的记录， 必要的科学、临床、行政和组织结构，以支持NIAID活动。

The Vaccine and Treatment Evaluation Units (VTEUs) are a critical resource for the NIAID Infectious Diseases Clinical Research Consortium to conduct clinical research and trials to evaluate vaccines, preventive biologics, therapeutics, diagnostics, predictive markers, and devices for the treatment and prevention of infectious diseases in people of all ages and risk categories. The VTEU network sites must flexible and respond to emerging threats and changing NIAID priorities. To this end, the University of Rochester VTEU (UR VTEU) will collaborate with NIAID and the VTEU leadership group (VTEU LG) to address and prioritize initiatives for infectious diseases such as respiratory, enteric, sexually transmitted infections and antibiotic resistant organisms as well as maintain flexibility to switch focus to emerging threats as the need arises. The University of Rochester is fortunate to enjoy a community with a very positive attitude towards clinical research and collaborative relationships between the major healthcare providers in the city providing access to all the hospitals, clinics and practices in the area. The UR VTEU offers a very experienced administrative and clinical group with a proven track record of successful multicenter clinical trial work. With the support of the VTEU LG, the UR VTEU will be well positioned to develop as well as implement concepts and projects that address important NIAID priorities and formulate best practices, efficiencies and standard operating procedures among VTEU sites. UR VTEU investigators have expertise in adult and pediatric clinical research as well as recruitment of vulnerable populations into clinical trials and thus can anticipate successful recruitment of young and older adults, infants, young children and adolescents, and pregnant women. Additionally, the close relationship of the Monroe County Health Department with the University provides access to patients with sexually transmitted diseases for study participation. We will provide capacity to perform phase 1-3 clinical trials and pharmacokinetic studies as well as surge capacity in terms of personnel and clinical research sites to rapidly respond to urgent NIAID demands. Importantly, our investigators have experience conducting challenge and isolation studies and can provide VTEU facilities for such projects. Our research laboratory expertise will provide the VTEU network with a variety of state of the art technologies to interrogate the host response to infection and immunization as well as develop a deeper understanding of pathogenesis for many infectious diseases. Specifically, core faculty have expertise in a wide range of novel immunologic assays as well as transcriptional and microbiome analysis. In addition, the UR VTEU will provide research opportunities and education for junior faculty to train the next generation of physician scientists. All clinical trials will adhere to NIAID/NIH requirements and comply with Good Clinical Practice. In summary, the UR VTEU site will offer an enthusiastic and diverse group of investigators with a track record of participating in collaborative research and the necessary scientific, clinical, administrative and organizational structure to support NIAID activities.