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).

抽象行政核心-IPCAVD - - E -DNA + ENV蛋白疫苗接种HIV 该程序的目的是生产增强的E/P传递基因调整的DNA疫苗（E-DNA）和 将其与高度新颖的多价A，B，C，A/E重组蛋白增强（PPB）作为疫苗平台相结合。 该应用的EP重点是利用新型的表面递送。通过这种组合，我们假设我们 与当前的HIV疫苗相比 方式。该项目以该团队成员的重大创新和成就为基础 已经提出了这一建议。该团队已经有效地合作了多年。此外，他们还有 与HVTN一起工作的生产力的杰出记录。将Chavi调查人员包括在内 临床前开发免疫分析是该计划的主要优势。有3个高度相互关联， 翻译成专注的，异常新颖的项目，建立在牢固的成就记录的基础上 共同完成此程序。它们得到了高度尊敬的，重要的蛋白质核的支持 经验丰富的行政核心。 行政核心（AC）负责总体程序性能，样本分布，程序化 监督，HVTN和NIH编程互动，并推荐SAB成员进行程序审查。 AC将安排年度SAB会议，并制定工作计划，以根据SAB的建议采取行动 NIH计划的指导。授予该计划的奖励后，将进行外部SAB。这 行政核心将安排团队呼吁进行公开数据讨论和时间列审查，安排每月电话 通过NIH计划，安排每月呼吁与PI和团队审查进度，安排双年度数据审查 会议并提供有关计划反馈进度的年度书面报告，并促进 调查结果和科学会议出席结果。 AC还将在季度更新HVTN 相对于程序化目标的基础。我们有一个既定的HVTN开发团队来促进这一过程 这将根据资助的该申请进行扩展（HVTN字母）。