University of Rochester Vaccine and Treatment Evaluation Unit(VTEU)- DMID-21-0004

罗切斯特大学疫苗和治疗评估单位 (VTEU)- DMID-21-0004

• 批准号: 10405144
• 负责人: Angela Ramona Branche
• 金额: $ 55.41万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-10 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10405144
• 关键词: Address; Adult; Age; Antibiotic-resistant organism; Antibiotics; Area; Biological Response Modifier Therapy; Categories; Child; Childhood; Cities; Clinic; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Communities; County; Data; Data Analyses; Development; Devices; Diagnostic; Disease; Disease Outbreaks; Drug Kinetics; Education; Elderly; Enrollment; Ensure; Enteral; Evaluation; Faculty; Genetic Transcription; Good Clinical Practice; Happiness; Health; Health Personnel; Hospitals; Human Resources; Immune response; Immunization; Immunology procedure; Infant; Infection; Influenza; Intervention; Investigation; Laboratories; Laboratory Research; Leadership; Malaria; Measles; Methods; Multi-Drug Resistance; Multi-Institutional Clinical Trial; Multicenter Trials; Mumps; National Institute of Allergy and Infectious Disease; Pathogenesis; Patients; Pertussis; Pharmacy facility; Phase; Physicians; Policies; Poliomyelitis; Positioning Attribute; Pregnant Women; Preparation; Prevention; Preventive; Procedures; Protocols documentation; Reporting; Research; Research Personnel; Resources; Risk; Sampling; Scientist; Secure; Sexually Transmitted Diseases; Site; Surgeon; Target Populations; Technology; Testing; Therapeutic; Time; Training; Tuberculosis; United States; United States National Institutes of Health; Universities; Vaccination; Vaccines; Virus; Vulnerable Populations; War; Work; clinical research site; combat; data management; design; drug resistant bacteria; experience; fight against; flexibility; improved; innovation; microbiome analysis; next generation; novel; novel therapeutics; novel vaccines; organizational structure; pathogen; pre-clinical research; predictive marker; premature; preservation; recruit; respiratory; vaccine access; vaccine evaluation; young adult; young woman

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. .

疫苗和治疗评估单位 (VTEU) 是 NIAID 传染病的重要资源 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病的疗法、诊断、预测标记和设备 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 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 生物体并保持灵活性，以便在需要时将重点转移到新出现的威胁上。大学 罗切斯特大学很幸运能享受到一个对临床研究和研究抱有非常积极态度的社区。 该市主要医疗保健提供者之间的合作关系提供了获得所有医疗服务的机会 该地区的医院、诊所和诊所。 UR VTEU 提供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记录。在 VTEU LG 的支持下， UR VTEU 将处于有利位置来开发和实施解决以下问题的概念和项目： NIAID 的重要优先事项，并在其中制定最佳实践、效率和标准操作程序 VTEU 站点。 UR VTEU 研究人员拥有成人和儿科临床研究方面的专业知识以及 招募弱势群体参加临床试验，从而可以预期成功招募年轻人 以及老年人、婴儿、幼儿和青少年以及孕妇。此外，关闭 门罗县卫生局与大学的关系为患有以下疾病的患者提供了接​​触机会 参与研究的性传播疾病。我们将提供进行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场所的激增能力 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 为 VTEU 网络提供各种最先进的技术来询问主机响应 感染和免疫以及对许多传染病的发病机制有更深入的了解 疾病。具体来说，核心教师拥有广泛的新型免疫学检测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 为初级教师提供教育，以培养下一代医师科学家。所有临床试验将遵循 NIAID/NIH 要求并遵守良好临床实践。总之，UR VTEU 网站将提供 热情且多元化的研究人员群体，具有参与合作研究和记录的记录 支持 NIAID 活动所需的科学、临床、行政和组织结构。 。