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.