Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required)

辛辛那提儿童医院医疗中心疫苗和治疗评估单位（需要 UM1 临床试验）

• 批准号: 10378359
• 负责人: Robert Wilson Frenck
• 金额: $ 56.69万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-26 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378359
• 关键词: Address; Adolescent; Adult; Affect; Age; Applied Research; Area; Award; Biological Assay; Biological Response Modifier Therapy; Budgets; Child; Clinical; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Consent Forms; Data Analyses; Development; Devices; Diagnostic; Disease; Disease Outbreaks; Elderly; Emerging Communicable Diseases; Enrollment; Ensure; Enteral; Epidemiology; Evaluation; Faculty; Future; Goals; Group Structure; Human; Immunocompromised Host; Infant; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H5N1 Subtype; Intervention Trial; Laboratories; Leadership; Letters; Life; Manuals; Medical center; Mentors; Methods; Microbiology; Mission; Modeling; Modification; Morbidity - disease rate; Multicenter Studies; National Institute of Allergy and Infectious Disease; Norovirus; Ohio; Outpatients; Participant; Pediatric Hospitals; Performance; Phase; Population; Pregnant Women; Preparation; Prevention; Preventive; Prognostic Marker; Protocols documentation; Public Health; Publications; Quality Control; Recording of previous events; Research Design; Research Personnel; Respiratory Tract Infections; Sexually Transmitted Diseases; Shigella sonnei; Site; Systems Biology; Technology; Testing; Therapeutic; Training; U-Series Cooperative Agreements; United States National Institutes of Health; Vaccines; biodefense; clinical research site; clinical trial implementation; data dissemination; data tools; design; emerging pathogen; enteric pathogen; infectious disease treatment; influenza virus vaccine; innovation; investigator-initiated trial; medical specialties; mortality; neglected tropical diseases; novel; operation; organizational structure; predictive marker; prevent; recruit; respiratory pathogen; response; trial design; vaccine candidate; vaccine development; vaccine effectiveness; vaccine evaluation; vaccine trial; vaccine-induced immunity

PROJECT SUMMARY Throughout history, infectious diseases have been, and continue to be, a leading cause of morbidity and mortality throughout the world. While all ages are affected by infectious diseases, the ends of the spectrum of life (young children and elderly) are particularly vulnerable. Thus, the prevention and treatment of infectious diseases through the development of vaccines, therapeutics, devices and diagnostics is a critical global priority. As a VTEU for nearly 25 years, we have provided the scientific, clinical, administrative, and organizational structure to support implementation of clinical trials and studies for the Division of Microbiology and Infectious Diseases (DMID) including respiratory infections, enteric diseases, sexually transmitted infections and neglected tropical diseases. Also, we are recognized experts in the area of human challenge infection models (CHIMs) of enteric and respiratory pathogens. Additionally we repeatedly have demonstrated the ability to provide surge capacity to address infectious disease outbreaks as evidenced by our responses to the testing of H5N1 and novel H1N1 influenza vaccines (for which we received a personal letter from Dr Anthony Fauci). To further expand the capabilities of our Unit; we have added expertise in epidemiology and vaccine effectiveness. We consistently have met or exceed enrollment goals and routinely have over 90% of our subjects complete the study. We consistently have exceeded contractual obligations, including rapid recruitment of subjects spanning the age spectrum including pregnant women. We have provided outstanding leadership of multi-center studies and have been excellent collaborators on studies led by other VTEU sites. We have developed investigator initiated trials and have assisted in the development of trials initiated by DMID. We also have undertaken vaccine projects incorporating systems biology to more deeply understand correlates of vaccine-induced immunity. We are extremely excited to continue as a VTEU, collaborating with the IDCRC, the Leadership Group, NIAID, and other Infectious Diseases experts under this NIAID Cooperative Agreement.

项目摘要 在整个历史上，传染病一直存在，并且继续是发病率和 全世界的死亡率。虽然所有年龄段都受到传染病的影响，但频谱的末端 生活（幼儿和老年人）特别脆弱。因此，预防和治疗传染性 通过疫苗，治疗剂，设备和诊断的疾病疾病是关键的全球 优先事项。 作为近25年的VTEU，我们提供了科学，临床，行政和组织 支持实施微生物学和传染性的临床试验和研究的结构 疾病（DMID），包括呼吸道感染，肠道疾病，性传播感染和 被忽视的热带疾病。此外，我们是人类挑战感染模型领域的公认专家 肠和呼吸道病原体的（CHIMS）。另外，我们反复证明了 提供涌动能力来解决传染病爆发的能力，这是我们对测试的反应证明的 H5N1和新颖的H1N1流感疫苗（我们收到了Anthony Fauci博士的个人信）。到 进一步扩大我们单位的功能；我们增加了流行病学和疫苗的专业知识 效力。 我们始终达到或超过注册目标，并经常拥有超过90％的主题 完成研究。我们始终超出了合同义务，包括快速招募 包括孕妇在内的年龄频谱的受试者。 我们提供了多中心研究的杰出领导 由其他VTEU站点领导的研究。我们已经开发了调查员发起的试验，并协助了 DMID发起的试验的发展。我们还承担了结合系统的疫苗项目 生物学更深入地了解疫苗诱导的免疫力的相关性。我们非常兴奋 继续担任VTEU，与IDCRC，领导力小组，NIAID和其他感染力合作 根据这项NIAID合作协议，疾病专家。