Core-001

核心001

• 批准号: 10782243
• 负责人: Richard Thomas Wyatt
• 金额: $ 139.64万
• 依托单位: SCRIPPS RESEARCH INSTITUTE, THE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-04 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10782243
• 关键词: Core; 001

Nonhuman primates (NHP) specifically, rhesus macaques (RMs), are a key animal model in investigating prevention strategies of HIV infection. This animal model of simian immunodeficiency virus (SIV)/ simian-human immunodeficiency virus (SHIV) infection has been utilized to elucidate both basic concepts in immunization and evaluate clinically relevant prevention approaches. RMs are ideal for investigating the humoral and cellular responses generated by HIV candidate immunizations and the impact on acquisition of infection. NHP studies require extensive coordination, expertise, personnel, and infrastructure. Therefore, the NHP Core (Core B) will support this HIVRAD research team by executing the four preclinical RM immunization studies proposed in Project 1. The animals will receive a variety of novel candidate immunogens and vaccine strategies. Their immune responses will be monitored throughout the study via collection of blood and tissues. Dependent upon those results, potentially, a select few animals will undergo viral challenge with SHIV to test the efficacy of the immunizations. Core B will support the success of this research program by 1) ensuring the adherence to regulatory approvals and procedures necessary for NHP research; 2) coordination of animal selection, assignment, substance administration and sample collection; 3) proper storage and shipment of all samples to the collaborating PIs and Cores; 4) coordination of data collection, analysis, and distribution; 5) and ensuring the monitoring of animal health over the course of the studies. This NHP core will work closely with the collaborators for the vaccine and challenge studies and will participate actively in the scientific mission of this HIVRAD. Further, it will ensure that all NHP research is integrated with the goals of this proposal and the evolving needs of the studies. Core B is led by Dr. Guido Silvestri, who has >20 years of experience leading NHP research projects involving complex study design and intervention, specifically, he has executed a large number of collaborative pre-clinical vaccine trials. During this research he was essential in investigating and developing novel sample collection techniques, such as lymph node fine needle aspirates, for the continued monitoring of germinal center responses during longitudinal studies. Core B will be based at Yerkes National Primate Research Center (YNPRC) at Emory University, this NIH-funded primate research center possesses all the proper animal resources and state-of-the-art veterinarian care expertise necessary to support the proposed work. As an integral part of this research program, the NHP Core will provide critical support to achieve the shared objectives of evaluating these proposed promising novel pre-clinical vaccines.

非人灵长类动物（NHP），特别是恒河猴（RM），是研究的关键动物模型 艾滋病毒感染的预防策略。这种猴免疫缺陷病毒（SIV）/猴-人的动物模型 免疫缺陷病毒（SHIV）感染已被用来阐明免疫的基本概念， 评估临床相关的预防方法。RM是研究体液和细胞免疫的理想工具。 艾滋病毒候选免疫接种产生的反应以及对感染的影响。NHP研究 需要广泛的协调、专业知识、人员和基础设施。因此，NHP核心（核心B）将 通过执行中提出的四项临床前RM免疫研究来支持该HIVRAD研究团队 项目1。这些动物将接受各种新的候选免疫原和疫苗策略。他们的 在整个研究期间，通过采集血液和组织监测免疫应答。取决于 根据这些结果，潜在地，选择的少数动物将经历用SHIV的病毒攻击以测试所述药物的功效。 免疫接种。核心B将通过以下方式支持本研究项目的成功：1）确保遵守 NHP研究所需的监管批准和程序; 2）动物选择的协调， 分配、物质管理和样品采集; 3）所有样品的适当储存和运输， 协作PI和核心; 4）协调数据收集、分析和分发; 5）确保 在研究过程中监测动物健康。该NHP核心将与合作者密切合作 为疫苗和挑战研究，并将积极参与科学使命的艾滋病毒。此外，本发明还 它将确保所有的NHP研究与本提案的目标和不断变化的需求相结合， 问题研究核心B由Guido Silvestri博士领导，他拥有超过20年领导NHP研究项目的经验 涉及复杂的研究设计和干预，具体来说，他已经执行了大量的合作， 临床前疫苗试验在这项研究中，他在调查和开发新的样品方面发挥了重要作用。 收集技术，如淋巴结细针抽吸物，用于持续监测生殖中心 纵向研究中的反应。核心B将设在耶基斯国家灵长类动物研究中心 在埃默里大学，这个由美国国立卫生研究院资助的灵长类动物研究中心拥有所有合适的动物， 支持拟议工作所需的资源和最先进的兽医护理专业知识。作为整体 作为该研究计划的一部分，NHP核心将为实现以下共同目标提供关键支持： 评估这些提出的有希望的新型临床前疫苗。