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: 10456399
• 负责人: Robert Wilson Frenck
• 金额: $ 26.83万
• 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: 2021-08-06 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456399
• 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.

项目总结 纵观历史，传染病一直是并将继续是发病率和死亡率的主要原因。 世界各地的死亡率。虽然所有年龄段的人都受到传染病的影响，但 生命(幼儿和老年人)尤其脆弱。因此，预防和治疗传染性疾病 通过疫苗、治疗方法、设备和诊断方法开发疾病是一个关键的全球 优先考虑。 作为一家拥有近25年历史的VTEU，我们提供了科学、临床、管理和组织方面的 支持微生物学和感染科临床试验和研究实施的结构 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，我们在人类挑战感染模型领域也是公认的专家 (CHIM)肠道和呼吸道病原体。此外，我们一再证明有能力 提供应对传染病爆发的激增能力，这从我们对测试的反应中可见一斑 H5N1和新型H1N1流感疫苗(我们收到了Anthony Fuci博士的亲笔信)。至 进一步扩大我们单位的能力；我们增加了流行病学和疫苗方面的专业知识 有效性。 我们一直达到或超过招生目标，我们的科目通常超过90% 完成研究。我们一直超过合同义务，包括迅速招聘 研究对象跨越各个年龄段，包括孕妇。 我们为多中心研究提供了杰出的领导，并在 由其他VTEU站点领导的研究。我们开发了调查员发起的试验，并协助 开发由DMID发起的试验。我们还开展了包含系统的疫苗项目 生物学更深入地了解疫苗诱导免疫的相关因素。我们非常兴奋能够 继续作为VTEU，与IDCRC、领导小组、NIAID和其他传染病合作 NIAID合作协议下的疾病专家。