Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required)-DMID 21-0012

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）-DMID 21-0012

• 批准号: 10402467
• 负责人: Robert Wilson Frenck
• 金额: $ 128.38万
• 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: 2021-07-20 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402467
• 关键词: Address; Age; Applied Research; Area; COVID-19 vaccine; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Conduct Clinical Trials; Development; Disease; Disease Outbreaks; Enrollment; Enteral; Epidemiology; Evaluation; Funding; Goals; Grant; Human; Infection; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H5N1 Subtype; Leadership; Letters; Medical center; Microbiology; Mission; Modeling; Multicenter Studies; National Institute of Allergy and Infectious Disease; Participant; Pediatric Hospitals; Pregnant Women; Resources; Respiratory Tract Infections; Sexually Transmitted Diseases; Site; Systems Biology; Testing; U-Series Cooperative Agreements; United States National Institutes of Health; Vaccines; clinical trial implementation; enteric pathogen; influenza virus vaccine; investigator-initiated trial; neglected tropical diseases; novel; organizational structure; parent grant; prevent; recruit; respiratory pathogen; response; vaccine effectiveness; vaccine trial; vaccine-induced immunity

PROJECT SUMMARY 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. The main focus of the parent grant is to provide funding to assemble and maintain the team needed to perform clinical trials. The supplemental funding will provide the resources needed to conduct COVID-19 vaccine trials. It is projected that with the supplemental funding, we will recruit, enroll and retain 90 participants over the 2 year period of the study.

项目摘要 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％的我们 受试者完成了研究。我们一直超出合同义务，包括快速 包括孕妇在内的年龄段的受试者的招募。我们提供了出色的 多中心研究的领导能力，并且一直是其他VTEU网站领导的研究的出色合作者。 我们已经开发了研究人员的启动试验，并协助开发了DMID发起的试验。 我们还进行了结合系统生物学的疫苗项目，以更深入地了解相关性 疫苗诱导的免疫力。我们很高兴能继续担任VTEU，与IDCRC合作， 根据这项NIAID合作协议，领导力小组，NIAID和其他传染病专家。 父母赠款的主要重点是提供资金来组装和维护团队的执行所需的资金 临床试验。补充资金将提供进行COVID-19-19疫苗试验所需的资源。 预计，通过补充资金，我们将在2个中招募，注册和保留90名参与者 研究的年期。