Vaccine and Infectious Disease Division
Graphic by Jim Woolace / Fred Hutch
BBE faculty play a unique role in the overall scientific community at Fred Hutch. They provide scientific leadership and collaborate extensively with laboratory and clinical science colleagues and provide leadership for statistical data management centers and modeling consortia worldwide.
Our researchers have wide research interests that include the measurement and analysis of immune responses, design and analysis of phase I-IV clinical trials of vaccines and other modalities for preventing pathogen infection and disease and modeling pathogen evolution and the public health impact of infectious disease interventions. This expertise is key to the success of our research partners and collaborators.
The Center for Inference and Dynamics of Infectious Diseases (CIDID) provides national and international leadership in computational, statistical, epidemiological, and dynamic modeling research, education and outreach, and public health policy related to infectious diseases and interventions. CIDID includes more than 20 core faculty at eight participating institutions and additional faculty affiliates and is led by M. Elizabeth Halloran, a BBE faculty member.
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, is based at FHI 360 Durham, NC. Its central network laboratory is at Johns Hopkins University, Baltimore, MD and its statistical and data management center is led by BBE faculty member Deborah Donnell and SCHARP is employed for clinical data management and statistical service support of the HPTN clinical pipeline. 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.
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 leadership group, laboratory program and statistical and data management center, the last of which is led by BBE Program Head, Peter Gilbert.
BBE contributes to important areas of all HVTN research, including protocol design and statistical methods for trial design and data analysis. As part of the BBE program, the SCHARP is employed for clinical and lab data management and statistical service support of the HVTN clinical pipeline.
The US-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 MTN is comprised of the leadership operations center (FHI 360 & UW), laboratory center (University of Pittsburgh and Magee-Womens Research Institute), and statistical and data management center, the last of which is led by BBE faculty member Elizabeth Brown. SCHARP is employed for clinical data management and statistical service support of the MTN clinical pipeline.
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical support and data management to BBE and other VIDD faculty for the HVTN, MTN, HPTN and VISC described above as well as other data management needs on a project by project basis. SCHARP was founded in 1992 and is directed by BBE faculty member Peter Guarino.
The Vaccine Immunology Statistical Center (VISC) is organized within the Bill and Melinda Gates Foundation’s Collaboration for AIDS Vaccine Discovery (CAVD) to provide services in the areas of statistical design and data analysis, a central repository for data from key CAVD studies, and support for laboratory data management. BBE faculty member Raphael Gottardo is the principal investigator and the diverse staff of VISC has expertise in the areas of biostatistics, immunologic assays, bioinformatics, data management, and information systems. VISC partners with SCHARP for management of lab data and other critical operational support.