Seattle-Lausanne Clinical Trials Unit

西雅图-洛桑临床试验单位（CTU）有一个共同的愿景，即生活在一个没有新的艾滋病毒感染的世界中 没有艾滋病相关的发病率和死亡率。为此，我们致力于加快 未来七年：1）开发全球有效的艾滋病毒疫苗， 可预防HIV免疫预防方案和预防分枝杆菌的改进的疫苗方案 结核病感染; 2）发现新的和改进的疗法，可以有效地治疗所有人的生活 与艾滋病毒，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资金的更新申请中，我们的CTU建议继续 支持艾滋病毒疫苗试验网络（HVTN）和艾滋病毒成人治疗网络的科学优先事项。 通过我们现有的三个高度整合的临床研究中心（CRS）：西雅图 疫苗试验单位（HVTN中心）、洛桑疫苗和免疫治疗中心（HVTN中心）和 华盛顿大学艾滋病临床试验单位（ACTG网站）。 我们的CTU正在代表网络进行富有成效和紧张的临床研究，我们 预期我们会从目前的工作组合顺利过渡到下一个周期开始的拟议新研究。 我们的CTU领导和合作调查员是网络领导和科学的宝贵成员。 委员会;他们主持并参与高调的首次人体研究，并带来创新设计，以获得 深入了解候选疫苗和新疗法实现其预期效果的机制， 应答此外，我们的CRS将继续在临床试验中招募和跟踪目标人群， 为推进有前景的免疫、抗病毒和其他治疗策略提供了出色的数据。 为了实现我们的愿景和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， 对HVTN和ACTG的创新。与此同时，我们的CTU将推进研究事业，领导技能和 为早期医生科学家提供机会，培养下一代网络调查员。在目标2中， 我们的治理和行政结构将提供一个透明的决策过程， 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，生产CTU。与HVTN和ACTG合作，在目标3中 我们的三个临床研究中心将在反恐小组的支持下进行1-4期临床试验，以确保最高质量 标准在目标4方面，我们会继续让社区伙伴参与，确保他们提供意见和支持， 优化临床研究活动中相关人群的入组和参与。重要的是我们 我们的三个机构承诺提供必要的资源来执行这一议程， 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。

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.