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

项目摘要 在整个历史上，传染病一直是并继续是发病率和死亡率的主要原因。 全世界的死亡率。虽然所有年龄段的人都受到传染病的影响， 生命（幼儿和老年人）特别脆弱。因此，预防和治疗传染性 通过开发疫苗、治疗方法、设备和诊断方法来预防疾病是一个关键的全球性问题， 要务 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 我们始终达到或超过招募目标，并且通常有超过90%的受试者 完成研究。我们一贯超额履行合同义务，包括迅速征聘 受试者年龄范围包括孕妇。 我们为多中心研究提供了出色的领导，并在以下方面成为优秀的合作者： 由其他VTEU站点领导的研究。我们开发了研究者发起的试验，并协助 开发由DMID发起的试验。我们还开展了疫苗项目， 生物学，以更深入地了解疫苗诱导免疫的相关性。我们非常兴奋地 继续作为一个VTEU，与IDCRC，领导小组，NIAID和其他传染病合作， 疾病专家根据该NIAID合作协议。

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.