Research Resource for Human Organs and Tissues (U42)

项目主任/首席调查员(最后、第一、中间)：Bell，Thomas，J. 项目名称：HTORR/NIAID高优先级HIV人类生物疫苗恢复计划 项目总结 开发有效的治疗方法或治疗范围广泛的疾病需要转化性研究， 与人类的病理生理学直接相关。人类生物有机体的使用在加速发展方面起着关键作用 通过为科学家提供直接的实验模型系统来推进艾滋病毒研究中的科学发现 了解艾滋病毒的预防、治疗、共病和治疗策略。要解决几个复杂的问题 艾滋病毒研究面临的问题，包括病毒持久性、潜伏期和重新激活以及优化 对于人类组织的保存方法，研究人员需要获得一种独特的资源，这种资源可以提供 严格和统一地从HIV阳性捐赠者的特定队列中收集人类生物样本，以产生 一致和可重复性的实验结果，用于创造性和开创性的研究。作为一个领军人物 作为生物医学研究社区的组织提供者，国家疾病研究交流中心(NDRI)是一个 501(C)(3)，非营利性组织，该组织仍然站在协调生物杀虫剂采购的前沿，以 符合先进的科学实验方法的需要，使尖端研究成为可能。已经过去了 30年来，NDRI已经收到了NIH的资金，用于这个行政副刊--人类 组织和器官研究资源(HTORR)U42授权号：U42OD011158。要解决更大的问题 超出HTORR范围的艾滋病毒研究领域的规模和更复杂的项目，NDRI是 扩大其生物菌种收集的能力，以符合更广泛的未得到满足或未得到充分代表的需求 在艾滋病毒研究领域。我们当前的计划年(PY)2努力包括提供严谨、大规模、 从高度确定的HIV+捐赠者队列中统一收集人类生物寄生虫以优化组织 研究艾滋病毒研究的保存方法，并研究病毒的持久性、潜伏期和重新激活。我们的目标是 PY3的建议是继续开发和实施大规模的生物菌种收集计划，以 为NIAID的高优先级艾滋病毒研究提供持续支持。为了实现这一目标，NDRI将：1)领导 发展大规模(每供体120等份)和复杂(每供体约30种组织类型)回收 项目，2)从NDRI的TSS和NIAID的艾滋病毒+捐赠者转介中确定和授权艾滋病毒+捐赠者，3) 收集有关艾滋病毒+捐赠者的数据，4)协调标准化生物检疫疫苗的采购、加工和 保存，以及5)将所有的生物标本分发到莱恩博士的实验室。在这样做的过程中，生物学家收集 并将优化保存方法，以支持生成高质量、可重现的数据 科学评论和出版。 相关性 改善对艾滋病毒感染者的治疗或找到治愈方法需要获得高素质的人类 适合使用最具挑战性的实验技术进行分析的生物样品。这种方法 为科学家提供了一个直接的实验模型系统，以促进对艾滋病毒预防、治愈、 合并症和治疗策略。我们计划第3年提案的总体目标是继续 为NIAID制定和实施高度专业化的、持续的人类生物样品收集计划 艾滋病毒研究计划。 OMB编号0925-0001/0002(批准的第03/2020版至2023年2月28日)续页格式页

Program Director/Principal Investigator (Last, First, Middle): Bell, Thomas, J. PROJECT TITLE: HTORR/ NIAID High Priority HIV Human Biospecimen Recovery Program PROJECT SUMMARY The development of effective treatments or cures for a wide range of diseases requires translational studies that are directly relevant to human pathophysiology. The use of human biospecimens plays a key role in accelerating scientific discoveries in HIV research by providing scientists with a direct experimental model system to advance understanding of HIV prevention, cure, co-morbidities, and therapeutic strategies. To address several complex issues facing HIV research, including viral persistence, latency and reactivation as well as optimizing preservation methods for human tissues, investigators require access to a unique resource that could provide rigorous and uniform collection of human biospecimens from defined cohorts of HIV positive donors to yield consistent and reproducible experimental results for inventive and groundbreaking studies. As a leading human tissue provider for the biomedical research community, the National Disease Research Interchange (NDRI) is a 501(c)(3), not-for-profit organization that remains at the forefront of coordinating biospecimen procurement to match the needs of advancing scientific experimental methodologies, enabling cutting-edge research. For over 30 years, NDRI has received NIH funding for the parent award to this administrative supplement, the Human Tissue and Organs for Research Resource (HTORR) U42 Grant Number: U42OD011158. To address larger scale and more complex projects in the field of HIV research that are beyond the scope of HTORR, NDRI is expanding its capabilities for the biospecimen collection to align with broader unmet or under represented needs in the field of HIV research. Our current Program Year (PY) 2 efforts include providing rigorous, large scale, uniform collection of human biospecimens from highly defined cohorts of HIV+ donors to optimize tissue preservation methods for HIV studies and to study viral persistence, latency and reactivation. The goal of our PY3 proposal is to continue developing and implementing a large-scale biospecimen collection program to provide ongoing support for high priority HIV studies for NIAID. To accomplish this goal, NDRI will: 1) lead the development of large scale (>120 aliquots per donor) and complex (~30 tissue types per donor) recovery projects, 2) identify and authorize HIV+ donors from both NDRI’s TSS and NIAID’s HIV+ donor referrals, 3) collect relevant HIV+ donor data, 4) coordinate standardized biospecimen procurement, processing, and preservation, and 5) distribute all biospecimens to Dr. Lane’s laboratory. In doing so, the biospecimen collection and preservation methods will be optimized to support the generation of high-quality, reproducible data for scientific review and publication. RELEVANCE Improving treatment for HIV infected patients or finding a cure requires access to high-quality human biospecimens that are suitable for analysis using the most challenging experimental techniques. This approach provides scientists with a direct experimental model system to advance understanding of HIV prevention, cure, co-morbidities, and therapeutic strategies. The overall objective of our Program Year 3 proposal is to continue developing and implementing a highly specialized, ongoing human biospecimen collection program for NIAID’s HIV research initiatives. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page Continuation Format Page