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

项目总结 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。我们始终达到或超过注册目标，通常超过90%的 受试者完成研究。我们一直超过合同义务，包括快速 招募不同年龄段的受试者，包括孕妇。我们为您提供了出色的 他是多中心研究的领导者，在VTEU其他站点领导的研究中一直是优秀的合作者。 我们开发了调查员发起的试验，并协助开发了DMID发起的试验。 我们还开展了结合系统生物学的疫苗项目，以更深入地了解相关因素 疫苗诱导的免疫力。我们非常高兴能继续作为VTEU，与IDCRC合作， 领导小组、NIAID和本NIAID合作协议下的其他传染病专家。 家长资助的主要重点是提供资金，以组建和维持执行任务所需的团队 临床试验。补充资金将提供开展新冠肺炎疫苗试验所需的资源。 预计有了补充资金，我们将在两年内招募、登记和保留90名参与者。 研究的年限。

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.