Vaccine and Infectious Disease Division
Networks and Collaborations
The Vaccine and Infectious Disease Division plays a key role in several large-scale research networks dedicated to the elimination of infectious diseases. Our faculty members lead administrative and scientific efforts within these networks – both at the Hutch and around the world. Through these collaborations, VIDD is leveraging comprehensive and efficient approaches to eliminate or reduce the morbidity and mortality of infectious diseases at home and abroad.
The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The network designs and conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy. The HVTN is comprised of the Vaccine Leadership Group, Laboratory Program, and Statistical and Data Management Center which are headquartered at the Fred Hutch and sponsored by the National Institutes of Health (NIH). The Network’s HIV Vaccine Trials Units are located at leading research institutions in 27 cities on four continents.
VIDD faculty are responsible for coordinating and supporting the research activities of all U.S. and international sites. Faculty and staff in VIDD contribute to important areas of all HVTN research, including protocol design and data analysis, thereby driving the scientific goals of the collaboration.
The U.S.-based Microbicide Trials Network (MTN) was established in 2006 as an HIV/AIDS clinical trials network. The mission of the MTN is to reduce the sexual transmission of HIV through the development and evaluation of products that reduce the transmission of HIV when applied topically to mucosal surfaces or when taken orally. MTN-affiliated researchers and partners work within a unique infrastructure specifically designed to facilitate the research required to support licensure of these products for widespread use. Faculty leadership drives the scientific vision to conduct rigorous and ethically sound clinical studies of microbicide safety and effectiveness. More than 25 clinical research sites are currently located in seven countries – Malawi, South Africa, Uganda, Zambia, Zimbabwe, India and the United States, with MTN-affiliated sites being added in Peru and Thailand.
The statistical and data management center for the MTN is housed within the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), part of VIDD’s Population Sciences program.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection.
The HPTN research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. The HPTN is committed to the highest ethical standards for its clinical trials and recognizes the importance of community engagement in all phases of the research process.
The HPTN was established in 2000, building on the work of the HIV Network for Prevention Trials (HIVNET). HPTN’s central operations center (CORE), is based at FHI 360 Durham, NC. Its central network laboratory (Network Lab) is at Johns Hopkins University, Baltimore, MD and its statistical and data management center is housed within the Statistical Center for HIV/AIDS Research and Prevention (SCHARP), part of VIDD’s Population Sciences program.
HPTN receives its funding from three NIH institutes: the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health and the National Institute on Drug Abuse.
defeatHIV, the Delaney Cell and Genome Engineering Initiative, is a Martin Delaney Collaboratory comprised of scientific investigators and clinicians, from both public and private research organizations, who are committed to finding a cure for HIV.
Led by Drs. Keith Jerome (VIDD) and Hans-Peter Kiem (CRD) here at the Fred Hutch, the defeatHIV Collaboratory also includes investigators from the University of Washington, Seattle Children’s Research Institute, Beckman Research Institute of the City of Hope (Duarte, Calif.), Sangamo BioSciences (Richmond, Calif), and the National Institute of Allergy and Infectious Disease (NIAID; Bethesda, Md.).
defeatHIV investigators include some of the world’s leaders in HIV virology, transplantation biology, genome modification and gene transfer, and are utilizing the latest cell and genome engineering approaches to target critical roadblocks in the fight against HIV/AIDS. Our efforts are focused on creating HIV-resistant stem cells that can halt the cycle of infection following transplant, and on developing HIV-specific endonucleases that will seek out and eliminate the long-lived HIV reservoirs that plague infected individuals despite successful antiretroviral therapy.
To this end, we have taken keen interest in the biological mechanisms that were exploited to facilitate the functional cure of Timothy Ray Brown (“The Berlin Patient”). We believe his successful transplantation therapy may serve as a model for new and more accessible therapy approaches that could be made available to the vast majority of HIV infected individuals.
defeatHIV is supported through a program sponsored by the National Institutes of Health (NIH) and the NIAID in honor of AIDS activist Martin Delaney. This program, called the Martin Delaney Collaboratory: Towards an HIV-1 cure, focuses on providing support for curative HIV research strategies and fostering partnerships between public and private research organizations. defeatHIV is one of only three funded Martin Delaney Collaboratories, which also include the Collaboratory of AIDS Researchers for Eradication (CARE) based at the University of North Carolina at Chapel Hill, and the Delaney AIDS Research Enterprise (DARE) at the University of California, San Francisco.
For more information on the defeatHIV Martin Delaney Collaboratory, please visit defeatHIV.org.
The Cancer Immunotherapy Trials Network (CITN) employs the collective expertise of top academic immunologists to design and conduct cancer therapy trials with the most promising immunotherapy agents prioritized for high potential in treating cancer, in collaboration with National Cancer Institute, foundation and industry partners. Our Vision is to facilitate broad availability of immunotherapy agents, with known and proven biologic function, for treating cancer patients.
The CITN is an offspring of the NCI Immunotherapy Agent Workshop, held in July 2007, where participants ranked a list of agents with high potential to serve as immunotherapeutic drugs for cancer. All of the prioritized agents had proven immunologic or physiologic function. Yet, even today, none are broadly available for testing in patients with cancer.
Building on the decisions made at the initial and two subsequent NCI prioritization workshops detailed below, the CITN will focus on conducting early phase clinical trials that use agents and novel regimens with consensus prioritization that are most likely to prove effective and lead to regulatory approval in the foreseeable future.
Strategy: The CITN has selected the following key areas:
- Focusing on agents with known and proven biologic function that have received consensus prioritization in previous NCI workshops
- Focusing on regimens with clear immunologic endpoints likely to inform the next phases of drug development—specifically, those that prospectively and predictably increase the number of T cells specific for known and defined antigens
- Developing regimens that can be applied in multiple circumstances by multiple investigators
- Providing high-quality immunogenicity and biomarker data that elucidate mechanisms of response or failure and thereby facilitate the design of subsequent trials
Dr. Mac Cheever is the Principal Investigator at CITN responsible for the Central Operations & Statistical Center (COSC). He is also the Director of the Solid Tumor Research for the Fred Hutch (FHCRC). For additional information about the CITN, please go to: http://citninfo.org
The Office of HIV/AIDS Network Coordination (HANC) works with the six HIV/AIDS clinical trials networks funded by the Division of AIDS (DAIDS) of the U.S. National Institutes of Health (NIH) with the intent of creating a more integrated, collaborative and flexible research structure. The networks are an affiliated group of national and international medical research institutions and investigators that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies, and HIV vaccines. They include the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials group (IMPAACT), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), and the Microbicide Trials Network (MTN).
HANC is based at the Fred Hutch in Seattle, Washington and has provided leadership and logistical support for cross-network coordination efforts since 2004. HANC’s mission is to support the science and operations of the networks by increasing efficiency and resource-sharing through coordination of critical activities across networks and with other research and advocacy partners. Efforts focus on: scientific leadership; site management and clinical trials logistics; behavioral science; communications; laboratory operations; the Legacy Project; training development and dissemination; harmonization of data management; development and application of consistent standards of performance evaluation; and facilitating effective community engagement in the research process. HANC is accountable in its activities to DAIDS and Network Leadership.
Jeffrey Schouten, MD, JD, AAHIVE, is the HANC Director and provides leadership and strategic direction for all of the cross-network coordination activities that the HANC project encompasses. The Director works closely with the Network Leaders and DAIDS to develop and implement strategies to coordinate activities and optimize collaboration between the networks and DAIDS and other funding and operational partners. Dr. Shouten has been the HANC Director since September 2008. He is a former general surgeon with a focus on surgical oncology. He has been involved in HIV clinical research and HIV primary care for more than a decade. He is also a clinical investigator at the University of Washington AIDS Clinical Trials Unit. Jeff also has a strong interest in HIV public policy. For additional information about HANC, please go to: https://www.hanc.info/Pages/default.aspx
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides scientific leadership, statistical design and analysis to infectious disease researchers around the world. Housed within the Population Sciences program of the Vaccine and Infectious Disease Division (VIDD), SCHARP provides vital statistical analysis and data management support for these networks as described above.