Vaccine and Treatment Evaluation Units (VTEU)

这项提议是为了继续支持疫苗治疗和评估股(VTEU) 并对RFA-AI-18-046做出回应。BCM VTEU将 做好传染病临床研究中临床研究的着力点 国际电信联盟(IDCRC)，由VTEU、领导小组(LG)和国家 过敏和传染病研究所(NIAID)。BCM团队由调查人员组成， 行政人员、护士、医生助理(PA)、药剂师、实验室技术员和 高资质的支持人员进行研究，以更好地理解、治疗、 预防和控制传染病(ID)，开展重点流行病学研究，并 应对突发公共卫生事件。BCM VTEU调查人员将利用他们的临床 与更大的研究专家社区的经验和沟通/互动 确定并提出临床研究概念，以便在IDCRC内进行讨论和审查。在……里面 他们在LG中的角色以及LG政策的指导下，BCM调查员将协助 审查所有提交的概念并确定其优先顺序，然后参与设计和 将批准的概念发展成协议，以便在VTEU网络中实施。 在制定议定书的过程中，BCM VTEU调查人员将评估 BCM站点执行研究的适宜性，和/或将帮助确定使用 现有的大型合作者网络，如果由LG指导的话。如果选择BCM VTEU作为 研究现场，BCM VTEU团队将按照良好临床实践和 适用法规，并协助数据分析和报告/发布。BCM 调查人员将利用他们的协作网络来确定并登上更多的网站 需要进行大规模研究，并提供地理和人口多样性 来认识一下NIAID的新兴ID优先研究领域。 该项目的具体目标是： 1.进行针对临床疫苗开发的临床研究(1-4期临床 试验)，人类实验性感染(流感和肠道病毒)，以及在 呼吸道、胃肠道和性传播感染的患者； 2.提供快速扩展的基础设施和能力以进行评估 对公共卫生具有重要意义的病原体的疫苗/疗法；以及 3.为对疫苗和ID临床研究感兴趣的初级研究人员提供指导。

This proposal is for continuation of support for a Vaccine Treatment and Evaluation Unit (VTEU) at Baylor College of Medicine (BCM) and is in response to RFA-AI-18-046. The BCM VTEU will serve as the focal point for clinical research within the Infectious Diseases Clinical Research Consortium (IDCRC), composed of the VTEUs, Leadership Group (LG) and the National Institutes of Allergy and Infectious Diseases (NIAID). The BCM team consists of investigators, administrators, nurses, physician's assistants (PAs), pharmacists, laboratory technicians and support personnel who are highly qualified to perform research to better understand, treat, prevent and control infectious diseases (ID), to perform focused epidemiological studies, and to respond to public health emergencies. The BCM VTEU investigators will utilize their clinical experience and communications/interactions with the larger community of research experts to identify and bring forth clinical research concepts for discussion and review within the IDCRC. In their role within the LG and as directed by the LG policies, the BCM investigators will assist in reviewing and prioritizing all submitted concepts, and then participate in the design and development of approved concepts into protocols for implementation within the VTEU network. During the process of developing a protocol, the BCM VTEU investigators will assess the suitability of the BCM site to perform the study, and/or will help identify additional sites using an existing large network of collaborators, if directed by the LG. If the BCM VTEU is selected as a study site, the BCM VTEU team will implement the study per Good Clinical Practices and applicable regulations, and assist with data analysis and reporting/publication. BCM investigators will leverage their collaborative network to identify and onboard additional sites needed to conduct large scale studies, and provide geographical and population diversity to meet NIAID's priority research area of emerging ID. The project's Specific Aims are: 1. Conduct clinical research addressing clinical vaccine development (Phases 1-4 clinical trials), human experimental infections (influenza and enteric viruses), and evaluations in patients with respiratory, gastrointestinal and sexually transmitted infections; 2. Provide infrastructure and capabilities for rapid expansion to evaluate vaccines/therapeutics for pathogens of public health importance; and 3. Provide mentoring to junior investigators with interest in vaccines & ID clinical research.