Seattle-Lausanne Clinical Trials Unit

西雅图-洛桑临床试验中心

• 批准号: 10306362
• 负责人: Margaret Juliana McElrath
• 金额: $ 38.61万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10306362
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Adult; Area; Cessation of life; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Support Unit; Clinical Trials Unit; Communication; Communities; Data; Decision Making; Development; Disease; Disease Management; Disease remission; Enrollment; Ensure; Environment; Epidemic; Fostering; Fred Hutchinson Cancer Research Center; Funding; Future; Goals; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; Immune; Immunotherapy; Infrastructure; Institution; International; Lead; Leadership; Link; Mentorship; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Persons; Pharmacy facility; Phase; Physicians; Population; Preventive vaccine; Process; Regimen; Research; Research Activity; Research Personnel; Research Priority; Resource Allocation; Resources; Scientist; Seasons; Site; Structure; Target Populations; Therapeutic; Therapeutic Clinical Trial; Tuberculosis; Tuberculosis Vaccines; Universities; Vaccines; Viral; Vision; Washington; base; career; clinical research site; comorbidity; design; experience; first-in-human; immunoprophylaxis; improved; innovation; insight; member; neutralizing antibody; next generation; novel; novel therapeutics; operation; pandemic disease; prevent; research study; response; skills; vaccine candidate; vaccine immunotherapy; vaccine trial; volunteer

The Seattle-Lausanne Clinical Trials Unit (CTU) has a common vision to live in a world without new HIV infections and free of AIDS-related morbidity and death. To this end, we are committed to accelerate progress over the next seven years to: 1) develop a globally effective HIV vaccine, a combination broad neutralizing antibody immunoprophylaxis regimen that can prevent HIV, and an improved vaccine regimen to prevent Mycobacterium tuberculosis infection; and 2) discover novel and improved therapies that can effectively treat all persons living with HIV, prevent HIV disease and its co-morbidities, and lead to sustained viral remission without the need for ongoing treatment. In this renewal application for NIAID funding in 2020-2027, our CTU proposes continued support of the scientific priorities of the HIV Vaccine Trials Network (HVTN) and the HIV Adult Therapeutic Network (ACTG), through our three existing and highly integrated Clinical Research Sites (CRSs): the Seattle Vaccine Trials Unit (HVTN site), the Lausanne Vaccine and Immunotherapy Center (HVTN site) and the University of Washington AIDS Clinical Trials Unit (ACTG site). Our CTU is operating in a productive and intense period of clinical research on behalf of the networks, and we anticipate a seamless transition from our current portfolio to the proposed new studies initiated in the next cycle. Our CTU leaders and co-investigators are valuable members of the networks’ leadership and scientific committees; they chair and participate in high profile first-in-human studies and bring innovative designs to gain insights into the mechanisms by which candidate vaccines and novel therapeutics achieve their desired responses. Furthermore, our CRSs will continue to enroll and follow target populations in clinical trials and contribute outstanding data to advance promising immune-based, antiviral, and other therapeutic strategies. To achieve our vision and address the networks’ priorities, in Aim 1 we will harness the collective, diverse expertise of three internationally recognized thought leaders in the HIV field to provide scientific leadership and innovation to the HVTN and ACTG. In parallel, our CTU will advance the research careers, leadership skills and opportunities for early-stage physician scientists to foster the next generation of network investigators. In Aim 2, our governance and administrative structure will provide a transparent process for decision-making and effective oversight of communication, resource allocation, pharmacy, clinical and regulatory operations, and quality management to enable a highly integrated, productive CTU. In partnership with the HVTN and ACTG, in Aim 3 our three CRSs will conduct phase 1-4 clinical trials with the CTU support necessary to ensure the highest quality standards. In Aim 4, we will continue to involve our community partners to ensure their input and support, and to optimize enrollment and engagement of relevant populations in our clinical research activities. Importantly, we have the necessary resource commitments from our three institutions as needed to carry out this agenda and will leverage specialized expertise in our rich environment to foster diversity and innovation.

西雅图-洛桑临床试验中心 (CTU) 的共同愿景是生活在一个没有新艾滋病毒感染的世界 没有与艾滋病相关的发病率和死亡率。为此，我们致力于加快推进 未来七年：1）开发一种全球有效的艾滋病毒疫苗，一种广泛的中和抗体组合 可以预防艾滋病毒的免疫预防方案，以及预防分枝杆菌的改进疫苗方案 结核感染； 2）发现可以有效治疗所有活着的人的新颖和改进的疗法 感染艾滋病毒，预防艾滋病毒疾病及其合并症，并导致持续的病毒缓解，而不需要 持续治疗。在 2020-2027 年 NIAID 资金续展申请中，我们的 CTU 建议继续 支持 HIV 疫苗试验网络 (HVTN) 和 HIV 成人治疗的科学优先事项 网络 (ACTG)，通过我们现有的三个高度集成的临床研究中心 (CRS)：西雅图 疫苗试验中心（HVTN 站点）、洛桑疫苗和免疫治疗中心（HVTN 站点）以及 华盛顿大学艾滋病临床试验中心（ACTG 网站）。 我们的 CTU 正处于代表网络的临床研究富有成效且紧张的时期，我们 预计从我们当前的投资组合到下一个周期启动的拟议新研究的无缝过渡。 我们的 CTU 领导者和共同研究者是网络领导力和科学领域的宝贵成员。 委员会；他们主持并参与了备受瞩目的首次人体研究，并带来创新设计以获得收益 深入了解候选疫苗和新型疗法实现预期目标的机制 回应。此外，我们的 CRS 将继续招募和跟踪临床试验中的目标人群， 贡献出色的数据来推进有前景的免疫、抗病毒和其他治疗策略。 为了实现我们的愿景并解决网络的优先事项，在目标 1 中，我们将利用集体的、多样化的 三位国际公认的艾滋病毒领域思想领袖的专业知识提供科学领导和 HVTN 和 ACTG 的创新。与此同时，我们的 CTU 将促进研究事业、领导技能和 为早期医师科学家培养下一代网络研究者的机会。在目标 2 中， 我们的治理和行政结构将为决策和有效提供透明的流程 监督沟通、资源分配、药房、临床和监管运营以及质量 管理，以实现高度集成、高效的 CTU。与 HVTN 和 ACTG 合作，实现目标 3 我们的三个 CRS 将在必要的 CTU 支持下进行 1-4 期临床试验，以确保最高质量 标准。在目标 4 中，我们将继续让社区合作伙伴参与，以确保他们的意见和支持，以及 优化相关人群的注册和参与我们的临床研究活动。重要的是，我们 我们的三个机构根据需要承诺提供必要的资源来执行这一议程，并且 将利用我们丰富的环境中的专业知识来促进多样性和创新。