University of Rochester Vaccine and Treatment Evaluation Unit(VTEU)-DMID 21-0012

疫苗和治疗评价单位(VTEU)是NIAID传染病的重要资源 临床研究联盟将进行临床研究和试验，以评估疫苗、预防性生物制品、 治疗、诊断、预测标记物和治疗和预防感染性疾病的设备 所有年龄段和风险类别的人都患有疾病。VTEU网络站点必须灵活并响应 新出现的威胁和不断变化的NIAID优先事项。为此，罗切斯特大学将 与NIAID和VTEU领导小组(VTEU LG)合作，解决以下计划并确定其优先顺序 呼吸道、肠道、性传播感染和抗生素耐药性等传染病 并保持灵活性，以便在需要时将重点转向新出现的威胁。这所大学 很幸运地享受到了一个对临床研究持非常积极态度的社区， 城市中的主要医疗保健提供者之间的协作关系，提供访问所有 该地区的医院、诊所和诊所。UR VTEU提供了非常有经验的管理和临床 集团拥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， UR VTEU将处于有利地位，能够制定和实施概念和项目，以解决 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。UVTEU调查员在成人和儿科临床研究以及 将弱势人群招募到临床试验中，从而可以预期成功招募年轻人 以及老年人、婴儿、儿童和青少年以及孕妇。此外，收盘时 门罗县卫生局与该大学的关系为患者提供了接触 性传播疾病参与研究。我们将提供执行1-3期临床的能力 试验和药代动力学研究以及人员和临床研究地点的激增能力 快速响应NIAID的紧急需求。重要的是，我们的调查人员有进行挑战的经验 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 向VTEU网络提供各种最新技术，以询问主机对 感染和免疫以及加深对许多传染性疾病的发病机制的了解 疾病。具体地说，核心教员拥有广泛的新型免疫学分析方面的专业知识以及 转录和微生物组分析。此外，UR VTEU将提供研究机会和 对初级教师进行教育，以培养下一代内科科学家。所有临床试验都将坚持 NIAID/NIH要求，并遵守良好的临床实践。总而言之，UR VTEU网站将提供 热情和多样化的调查小组，有参与合作研究和 支持NIAID活动的必要的科学、临床、行政和组织结构。 。

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. .