University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric Study

罗切斯特大学疫苗和治疗评估单位 (VTEU)-mRNA-1273-P204 Moderna 儿科研究

• 批准号: 10380976
• 负责人: Angela Ramona Branche
• 金额: $ 114.44万
• 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: 2021-05-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380976
• 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; Moderna COVID-19 vaccine; 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（VTEUS）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， 治疗和预防感染性治疗和预防的治疗学，诊断，预测标记和设备 各个年龄段和风险类别的人的疾病。 VTEU网络站点必须灵活并响应 新兴威胁和改变NIAID的优先事项。为此，罗切斯特大学VTEU大学（Ur Vteu）将 与NIAID和VTEU领导力小组（VTEU LG）合作，以解决并优先考虑 传染病，例如呼吸道，肠性，性传播感染和抗生素耐药性 生物体以及在需要时保持灵活性，以将重点转换为新兴威胁。大学 罗切斯特（Rochester）很幸运地享受一个对临床研究和 城市中主要医疗保健提供者之间的合作关系，提供了所有人的访问权限 该地区的医院，诊所和实践。 Ur Vteu提供了非常有经验的行政和临床 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， UR VTEU将有能力开发以及实施解决方案的概念和项目 重要的NIAID优先事项，并在 VTEU站点。 Ur VTEU研究人员在成人和小儿临床研究方面都有专业知识以及 将弱势群体招募到临床试验中，因此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。另外，近距离 门罗县卫生部与大学的关系提供了与患者的访问权限 性传播疾病进行研究。我们将提供执行1-3阶段临床的能力 在人员和临床研究地点方面，试验和药代动力学研究以及激增的能力 快速响应紧急的NIAID需求。重要的是，我们的调查人员有经验挑战的经验 和隔离研究，可以为此类项目提供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，以询问主机的响应 感染和免疫，以及对许多感染性的发病机理的更深入了解 疾病。具体而言，核心教师在各种新型免疫学测定中具有专业知识， 转录和微生物组分析。此外，Ur VTEU将提供研究机会和 初级教师的教育培训下一代医师科学家。所有临床试验都将遵守 NIAID/NIH的要求，符合良好的临床实践。总而言之，Ur Vteu网站将提供 热情和多样化的调查员群体参与协作研究和 支持NIAID活动的必要科学，临床，行政和组织结构。 。