HTORR/ NIAID High Priority HIV Human Biospecimen Recovery Program

项目负责人/主要研究者（最后，第一，中间）：Bell，托马斯，J。 项目摘要 开发有效的治疗或治愈多种疾病的方法需要转化研究， 与人类病理生理学直接相关。人类生物标本的使用在加速 通过为科学家提供直接的实验模型系统， 了解艾滋病毒的预防、治疗、合并症和治疗策略。为了解决几个复杂的 艾滋病毒研究面临的问题，包括病毒的持久性，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， 从确定的HIV阳性供体队列中严格、统一地采集人体生物标本， 一致和可重复的实验结果，用于创造性和开创性的研究。作为一个人类领袖 作为生物医学研究界的组织提供者，国家疾病研究交流中心（NDRI）是一个 501（c）（3），非营利组织，仍然处于协调生物标本采购的最前沿， 满足推进科学实验方法的需求，实现尖端研究。超过 30年来，NDRI已经收到了NIH的资助，作为对这一行政补充的母基金， 研究资源组织和器官（HTORR）U42授权编号：U42 OD 011158。为了解决更大的 在艾滋病毒研究领域，NDRI的规模和更复杂的项目超出了HTORR的范围， 扩大其生物标本采集能力，以满足更广泛的未满足或代表性不足的需求 在艾滋病研究领域。我们目前的计划年（PY）1的努力包括提供严格的，大规模的， 从高度确定的HIV+阳性队列中统一采集人体生物标本，以优化组织 保存方法，用于艾滋病毒研究和研究病毒的持久性，潜伏期和再激活。我们的目标 PY 2提案是继续开发和实施大规模生物标本采集计划， 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 开发大规模（每个供体>120等份）和复杂（每个供体>30种组织类型）回收 2）确定和批准高度界定的艾滋病毒+捐助者群体，3）收集相关的艾滋病毒+捐助者数据，4） 协调标准化生物标本的采购、处理和保存，以及5）分发 送到莱恩博士的实验室在此过程中，生物标本的采集和保存方法将 优化以支持生成高质量、可重复的数据，用于科学审查和出版。 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质量的人力资源， 生物标本，适合使用最具挑战性的实验技术进行分析。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，治疗， 共病和治疗策略。我们第二年计划提案的总体目标是继续 为NIAID制定和实施一个高度专业化的、持续的人类生物标本收集计划 艾滋病毒研究举措。 OMB编号0925-0001/0002（修订版03/2020批准至02/28/2023）页码继续格式页码

Program Director/Principal Investigator (Last, First, Middle): Bell, Thomas, J. 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) 1 efforts include providing rigorous, large scale, uniform collection of human biospecimens from highly defined cohorts of HIV+ positive to optimize tissue preservation methods for HIV studies and to study viral persistence, latency and reactivation. The goal of our PY2 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 highly defined cohorts of HIV+ donors, 3) collect relevant HIV+ donor data, 4) coordinate standardized biospecimen procurement, processing, and preservation, and 5) distribute 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 2 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