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

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 支持微生物和传染病科实施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 被忽视的热带病此外，我们是人类挑战感染模型领域的公认专家 （CHIMs）的肠道和呼吸道病原体。此外，我们一再证明， 提供快速部署能力，以应对传染病爆发，我们对检测 H5 N1和新型H1N1流感疫苗（我们收到了Anthony Fauci博士的私人信件）。到 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门知识 有效性我们一直达到或超过招生目标，并经常有超过90%的我们的 受试者完成研究。我们一直在超越合同义务，包括快速 招募年龄范围内的受试者，包括孕妇。我们提供了出色的 领导多中心研究，并一直是其他VTEU研究中心领导的研究的优秀合作者。 我们开发了研究者发起的试验，并协助开发了DMID发起的试验。 我们还开展了疫苗项目，将系统生物学纳入其中，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，和其他传染病专家根据本NIAID合作协议。 家长补助金的主要重点是提供资金，以组装和维持所需的团队执行 临床试验补充资金将提供进行COVID-19疫苗试验所需的资源。 预计在获得补充资金的情况下，我们将在2015年招募、登记和保留90名参与者。 研究的一年时间。

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.