Correlates of protective immunity to HCV and rational vaccine design: Admin Core

摘要 在这个项目中，我们建议确定个体中自发清除的保护的相关性 多起丙型肝炎病毒感染事件。这将为下一代汽车的设计提供非常有价值的信息 疫苗。我们的目标是评估抗原特异性T和B细胞反应在感染结局中的作用 基于模拟的非人灵长类动物免疫策略产生有效免疫应答 成功解决人类患者自然再暴露和再感染的问题。 这份U19提案包括3个项目和两个核心，包括一个行政核心A和一个临床核心 核心B.行政核心A将提供两项职能：(1)提供全面行政监督和 支持该方案和(2)为个人提供生物统计分析和数据管理支持 项目和核心。该管理核心将由埃默里大学的Grakoui博士领导，并将提供 为有效和高效地利用资源和由此产生的中间成果而进行的必要协调 合作努力。主要职能将是促进项目负责人之间的科学互动，如 同时也是核心领导者。行政部门将发挥领导作用，确保实现里程碑， 评估核心职能，修改科学目标，纳入任何新的合作者， 正在进行的优先次序和资源重新分配的决定。关键决定将在协商中做出 与美国国立卫生研究院的项目负责人和项目官员合作。行政核心将向NIH提交年度报告。 行政核心将维护预算并监督满足计划所需的任何重新预算 目标。行政核心的生物统计部分将提供数据管理和统计支助 这三个项目。此外，生物静力学部分将建立和维护适当的数据库， 应调查人员的要求进行管理和分析。为了提供服务以满足 分析挑战核心将包括促进处理复杂统计问题所需的方法 在各种研究项目中遇到的问题。此外，提供临床医生之间的基本指标， 科学家和生物统计学家。拥有专门用于生物统计和数据管理需求的资源 在这里提出的研究，将为研究的质量和生产力增加巨大的价值 并将这一信息正确地传播给科学界。

Abstract In this program, we propose to determine the correlates of protection in individuals that spontaneously clear multiple HCV infection episodes. This will give highly valuable information for the design of next generation of vaccines. Our goal to assess the role of antigen-specific T and B cell responses in infection outcome and to generate an efficacious immune response by vaccination strategies in non-human primates based on emulating successful resolution of natural re-exposure and re-infection in human patients. This U19 proposal consists of 3 Projects and two Cores consisting of an Administrative Core A and a Clinical Core B. The Administrative Core A will provide two functions: (i) provide overall administrative oversight and support for the Program and (ii) provide biostatistical analyses and data management support for the individual projects and Cores. This Administrative Core will be led by Dr. Grakoui at Emory University and will provide the coordination necessary to make effective and efficient use of resources and intermediate results from this collaborative effort. The primary function will be to facilitate scientific interactions between the Project leaders as well as Core leaders. The administrative component will provide the leadership to ensure milestones are met, assessment of the Core functions, modification of scientific goals, incorporation of any new collaborators, decisions of ongoing prioritization and reallocation of resources. Critical decisions will be made in consultation with the Project leaders and program official at NIH. The Administrative Core will file annual reports to the NIH. The Administrative Core will maintain budgets and oversee any re-budgeting that is needed to meet program goals. The biostatistics portion of the Administrative Core will provide data management and statistical support for the three projects. In addition, the Biostatics portion will establish and maintain appropriate database, management and analysis in response to investigators' requests. In order to provide services to meet the analytical challenges the Core will include facilitating methodologies necessary for addressing complex statistical issues encountered in various research projects. In addition, provide essential metrics between the clinicians, scientists and biostatisticians. Having resources dedicated to the biostatistics and data management needs for the research proposed here, will add enormous value to the quality and productivity of the research conducted by the Investigators and to disseminate this information correctly to the scientific community.