Administration

行政

• 批准号: 9261462
• 负责人: DAVID B. WEINER
• 金额: $ 21.39万
• 依托单位: WISTAR INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2020-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9261462
• 关键词: Adjuvant; Animals; Award; Biological Assay; Biometry; Biostatistics Core; Clinical; Clinical Research; Core Protein; DNA; DNA Vaccines; Data; Development; Devices; Feedback; Financial Support; Funding; Genes; Goals; HIV; HIV Vaccine Trials Network; HIV vaccine; Human; Immune; Immune response; Letters; Modality; Notification; Outcome; Performance; Process; Productivity; Program Reviews; Publications; Reagent; Recombinant Proteins; Reporting; Research Personnel; Resources; Sampling; Seasons; Statistical Data Interpretation; Suggestion; Surface; Time; United States National Institutes of Health; Update; Vaccination; Vaccines; Work; base; data sharing; env Gene Products; improved; innovation; meetings; member; novel; open data; pre-clinical; preclinical development; programs; synthetic construct

Abstract Administrative Core - IPCAVD -– E-DNA + Env protein Vaccination for HIV The goal of this program to produce an enhanced E/P delivered gene adjuvanted DNA vaccine (E-DNA) and combine this with a highly novel polyvalent A, B, C, A/E recombinant protein boost (PPB) as a vaccine platform. The EP focus of this application is to utilize novel surface delivery. By this combination we hypothesize that we will generate an improved spectrum of T and B anti HIV immune responses compared to current HIV vaccine modalities. This project builds on a major innovations and accomplishments by the members of this team that have led to this proposal. The team has worked together productively for multiple years. Furthermore they have an outstanding track record of productivity working with the HVTN. The inclusion of CHAVI investigators as part of the preclinical development immune analysis is a major strength of the program. There are 3 highly interrelated, translational focused, exceptionally novel projects which build on a strong track record of accomplishment together that comprise this program. They are supported by a highly respected, important protein core as well as seasoned administrative core. The Administrative core (AC) is responsible for overall program performance, sample distribution, programmatic oversight, HVTN and NIH Programmatic interactions and for recommending SAB members for program review. The AC will arrange the annual SAB meeting and put in place a work plan to act on the SAB’s suggestions with guidance of NIH program. The external SAB will be put in place upon notification of award of this program. The administrative core will arrange team calls for open data discussion, and time line review, arrange monthly calls with NIH program, arrange monthly calls to review progress with the PI and teams, arrange biannual data review meetings and provide yearly written reports on progress for program feedback as well as facilitate publication of findings and scientific meeting attendance for result reporting. The AC will also update the HVTN on a quarterly basis relative to programmatic goals. We have an established HVTN development team to facilitate this process and this will be expanded based on this application being funded (HVTN letter).

摘要管理核心- IPCAVD -- E-DNA + Env蛋白疫苗用于HIV 该计划的目标是生产增强的E/P递送的基因佐剂DNA疫苗（E-DNA）， 将其与高度新颖的多价A、B、C、A/E重组蛋白加强（PPB）结合作为疫苗平台。 本申请的EP重点是利用新型表面递送。通过这种组合，我们假设， 与目前的HIV疫苗相比，将产生改进的T和B抗HIV免疫应答谱 方式。该项目建立在该团队成员的重大创新和成就之上， 导致了这个提议。该团队多年来一直富有成效地合作。此外，他们有一个 与HVTN合作的生产力的出色记录。CHAVI调查员的参与， 临床前开发免疫分析是该计划的主要优势。有三个高度相关的， 以翻译为重点，非常新颖的项目，建立在良好的成就记录之上 共同组成了这个项目。他们是由一个备受尊敬的，重要的蛋白质核心，以及 经验丰富的行政核心。 行政核心（AC）负责整个计划的执行，样本分发， 监督、HVTN和NIH项目互动，并推荐SAB成员进行项目审查。 审计委员会将安排审计咨询委员会的年度会议，并制定一项工作计划， NIH计划的指导。外部SAB将在收到授予该计划的通知后到位。的 行政核心将安排团队电话进行开放数据讨论和时间线审查，并安排每月电话会议 与NIH项目，安排每月电话会议，与PI和团队一起审查进展，安排一年两次的数据审查 会议，并提供年度书面报告的进展情况，为计划的反馈，以及促进出版， 研究结果和出席科学会议以报告结果。AC还将每季度更新HVTN 与方案目标相关的基础。我们有一个成熟的HVTN开发团队来促进这一过程 这将扩大基于此应用程序正在资助（HVTN信）。