Clinical Core

临床核心

• 批准号: 7696466
• 负责人: Octavio Ramilo
• 金额: $ 30.61万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7696466
• 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; Contracts; Data; Dendritic Cells; Goals; Human; Immune; Immune response; Immunization; Immunology; Individual; Infection; Infectious Diseases Research; 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; clinical practice; clinically significant; cohort; cost; 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.

临床核心旨在提供集中的临床专业知识，以进行人类受试者的研究 促进和支持中心的最终目标，即通过靶向优化粘膜免疫 树突状细胞亚群。该核心将按照良好临床实践的最高标准运作 （GCP）。我们对人类受试者的研究将包括： a) 健康正常的志愿者，他们将接种 licensed influenza vaccines; b) 患有自然获得性流感感染的个体。我们已发起 对由美国开发的不同候选疫苗进行仔细而详细的测试和评估过程 该中心使用了许多体外测定和体内模型，包括 Humouse 和 非人类灵长类动物。我们必须并排分析最常见的免疫反应。 有希望的候选疫苗，在获得许可的免疫后产生免疫反应 流感疫苗和自然获得性感染。该临床核心将利用已建立的 基础设施和在上一次 U19 中心颁奖期间发起的成功合作 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： AIM 1. 获得连续的临床样本，包括鼻洗液 以及来自一组健康成年志愿者的血液样本，这些志愿者都接种了减毒活疫苗（LAIV） and inactivated influenza (TIV) vaccines.目的2.通过细胞分离术获得大量免疫细胞 对少数接种疫苗的健康志愿者的免疫反应进行详细分析 LAIV 和 TIV。目标 3. 获取连续的临床样本（鼻洗液和血液）以评估免疫 患有自然流感的先前健康成年人（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 高质量的临床样本，用于跨项目提出的不同分析和免疫研究 该中心促进中心调查人员的工作，并提供协同和整合。这 基础设施将以高效且具有成本效益的方式优化样本和资源的使用。