Clinical Core

临床核心是为在人类受试者中进行研究提供集中的临床专业知识 促进和支持该中心的最终目标，即通过靶向优化粘膜免疫 树突状细胞亚群。这一核心将按照良好临床实践的最高标准运行 (GCP)。我们在人类受试者身上的研究将包括：a)健康的正常志愿者，他们将接种 获得许可的流感疫苗；和b)自然获得流感感染的个人。我们已经发起了 由开发的不同候选疫苗的测试和评估的仔细和详细的过程 该中心使用了许多体外分析和体内模型，包括人类和 非人灵长类动物。我们必须并排分析MOST诱导的免疫反应 有希望的候选疫苗具有在获得许可的情况下免疫后产生的免疫反应 流感疫苗和自然获得性感染。这一临床核心将利用现有的 在上一届U19中心奖期间启动的基础设施和成功的协作 北卡罗来纳大学的研究人员和德克萨斯大学西南医学中心的传染病临床研究人员。 我们的研究将包括三个目标：目标1.获得连续的临床样本，包括鼻腔冲洗 和一组健康的成年志愿者的血液样本，用两种活疫苗(LAIV)免疫 和灭活流感(TIV)疫苗。目的2.通过细胞分离获得大量的免疫细胞 为了对少数健康志愿者进行详细的免疫反应分析 LAIV和TIV。目的3.获取序贯临床样本(鼻腔冲洗和血液)以评估免疫 患上自然流感的健康成年人(与志愿者年龄匹配)的反应 感染。通过将所有拟议的临床研究整合到一个统一的结构中，临床核心将提供 为不同的分析和免疫研究项目提供高质量的临床样本 该中心为中心调查人员的工作提供便利，并提供协同和整合。这 基础设施将以高效和具有成本效益的方式优化样品和资源的使用。

The Clinical Core is to provide centralized clinical expertise for conducting research in human subjects to facilitate and support the ultimate goals of the Center, which is to optimize mucosal immunity via targeting dendritic cell subsets. This Core will operate according to the highest standards of good clinical practice (GCP). Our studies in human subjects will include: a) healthy normal volunteers who will be immunized with licensed influenza vaccines; and b) individuals with naturally-acquired influenza infection. We have initiated a careful and detailed process for testing and evaluation of the different vaccine candidates developed by the Center using a number of in vitro assays and in vivo models, including both Humouse and the nonhuman primates. It is essential that we analyze side by side the immune responses induced by the most promising vaccine candidates with the immune responses generated after immunization with licensed influenza vaccines and naturally acquired infection. This Clinical Core will take advantage of the established infrastructure and successful collaboration initiated during the previous U19 Center award between the investigators at BUR and the infectious diseases clinical investigators at UT Southwestern Medical Center. Our studies will include three aims: AIM 1. To obtain sequential clinical samples including both nasal wash and blood specimens from a group of healthy adult volunteers immunized with both live attenuated (LAIV) and inactivated influenza (TIV) vaccines. AIM 2. To obtain large numbers of immune cells via cell apheresis to perform detailed analysis of immune responses in a small number of healthy volunteers immunized with' LAIV and TIV. AIM 3. To obtain sequential clinical samples (nasal wash and blood) to assess immune responses in previously healthy adults (age-matched with volunteers) who develop natural influenza infection. By consolidating all proposed clinical studies in one unified structure, the Clinical Core will provide high-quality clinical samples for the different analyses and immune studies proposed across the projects in the Center facilitating the work of the Center investigators,and providing synergy and integration. This infrastructure will optimize the use of samples and resources in an efficient and cost-effective manner.