Clinical Core

临床核心

• 批准号: 8377861
• 负责人: Octavio Ramilo
• 金额: $ 15.98万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8377861
• 关键词: Acute; Adult; Age; Age-Years; Attenuated; Award; Biological Assay; Blood; Blood Component Removal; Blood specimen; Cell Count; Cells; Characteristics; Clinical; Clinical Investigator; Clinical Research; Collaborations; Communicable Diseases; Contracts; Data; Dendritic Cells; Goals; Good Clinical Practice; Human; Immune; Immune response; Immunization; Immunology; Individual; Infection; Influenza; Institutes; Leukapheresis; Licensing; Life; Measures; Medical center; Mission; Mucosal Immunity; Mucous Membrane; Nasal Lavage Fluid; Population; Process; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Resources; Respiratory System; Respiratory tract structure; Sampling; Side; Specimen; Structure; Time; Upper respiratory tract; Vaccinated; Vaccination; Vaccines; Work; cohort; cost effective; evaluation/testing; healthy volunteer; high standard; human subject; improved; in vitro Assay; in vivo Model; influenza virus vaccine; influenzavirus; nonhuman primate; novel; response; seasonal influenza; vaccine candidate; volunteer

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.

临床核心是为在人类受试者中开展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 树突状细胞亚群本核心将按照最高标准的药物临床试验质量管理规范运行 （GCP）。我们在人类受试者中的研究将包括： 许可的流感疫苗;和B）具有天然获得性流感感染的个体。我们已开始 对开发的不同候选疫苗进行仔细和详细的测试和评估的过程， 该中心使用了许多体外试验和体内模型，包括Humouse和 非人类灵长类动物重要的是，我们要分析并排的免疫反应引起的最 有希望的候选疫苗，在用许可的疫苗免疫后产生免疫应答， 流感疫苗和自然获得性感染。该临床核心将利用现有的 基础设施和成功的合作，在以前的U19中心之间的奖项， BUR的研究人员和UT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。为了获得连续的临床样本，包括鼻洗液和 和来自一组健康成年志愿者的血液样本， 和灭活流感（TIV）疫苗。AIM 2.通过细胞单采术获得大量免疫细胞 为了对用“免疫”的少量健康志愿者的免疫应答进行详细分析， LAIV和TIV。AIM 3.获得连续临床样本（鼻洗液和血液），以评估免疫 既往健康成人（与志愿者年龄匹配）发生自然流感后的反应 感染通过将所有拟议的临床研究合并到一个统一的结构中，临床核心将提供 高质量的临床样本，用于不同的分析和免疫研究， 中心促进中心调查人员的工作，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本和资源的使用。