Document text
Principal Investigator: David W Haas
Organization: VANDERBILT UNIVERSITY MEDICAL CENTER
Fiscal Year: 2024
Award: $2,649,501
Funding agency: National Institute of Allergy and Infectious Diseases
PROJECT SUMMARY/ABSTRACT
The HIV pandemic is one of the greatest ongoing threats to health and development, over 35 years past its
recognition. The NIAID-funded Clinical Trials Networks have played critical roles in the coordinated response to
key research questions in the HIV/AIDS field, which will contribute to ultimately ending the HIV epidemic. The
Vanderbilt HIV Clinical Trials Unit (CTU) will continue the established partnership between Vanderbilt University
Medical Center in Nashville, Tennessee, and Washington University in St. Louis, Missouri, which are located in
a region of the United States with high incidence and prevalence of HIV. This CTU comprises three highly
productive Clinical Research Sites (CRSs) that contribute to three Networks - the therapeutics mission of the
AIDS Clinical Trials Group (ACTG), the vaccine mission of the HIV Vaccine Trials Network (HVTN), and the non-
vaccine prevention mission of the HIV Prevention Trials Network (HPTN). The Vanderbilt Vaccine CRS and
Washington University Therapeutics CRS have been members of the HVTN and ACTG since the inception of
these Networks in 1987-1988. The Vanderbilt Therapeutics CRS joined the ACTG in 2000. To contribute more
broadly to the Networks, Washington University has provided protocol-specific enrollment to the HPTN since
2016, and proposes to become a full member site of the HPTN, as the Washington University Prevention &
Therapeutics CRS. Leaders of this CTU have made high-impact scientific and programmatic contributions to the
Networks in areas that include human genomics, contemporary HIV-associated comorbidities, neurological
aspects of HIV disease, immunology of vaccine response, and beyond. During the proposed funding period, the
Vanderbilt CTU will continue to make substantial contributions to the ACTG, HVTN and HPTN's scientific
priorities. ACTG sites at both Vanderbilt and Washington University will focus on strategies to improve the health
of people living with HIV/AIDS, tuberculosis, and viral hepatitis. The Vanderbilt HVTN site will contribute both
study participants and cutting-edge immunologic technologies to further the major scientific priority of developing
and testing a safe and effective vaccine for HIV. The Washington University site will additionally contribute to
HPTN's emphasis on long-acting agents for pre-exposure prophylaxis, developing multipurpose technologies
such as combining HIV prevention with contraception, and strategies integrating biomedical, behavioral and
structural interventions for prevention. All CRSs of this CTU have an established record of success in enrolling
participants to clinical trials and conducting studies with utmost fidelity to ensure participant safety and quality
data advancing the science of HIV treatment and prevention.
Terms: <AACTG><ACTG><AIDS><AIDS Virus><AIDS clinical trial group><AIDS prevention><AIDS/HIV><Academic Medical Centers><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Affect><Antibody titer measurement><Area><Behavioral><Biological><Clinical Trials><Clinical Trials Network><Clinical Trials Unit><Collaborations><Communities><Contraception><Contraceptive methods><Country><County><DNA Molecular Biology><Data><Development><Disease><Disorder><Enrollment><Ensure><Epidemic><Epidemiology><Event><Fertility Control><Functional Metagenomics><Funding><Groups at risk><HBV><HIV><HIV Infections><HIV Prevention><HIV Vaccine Trials Network><HIV prevention trial><HIV prevention trials network><HIV vaccine><HIV-1><HIV-I><HIV/AIDS><HIV/AIDS Vaccines><HIV/AIDS prevention><HIV1><HTLV-III Infections><HTLV-III-LAV Infections><HVTN><Health><Hepatitis B Virus><Homologous Serum Hepatitis Virus><Human Immunodeficiency Virus Type 1><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Human immunodeficiency virus 1><Immune response><Immunochemical Immunologic><Immunologic><Immunological><Immunological response><Immunologically><Immunologics><Immunology><Incidence><Infection><Inhibition of Fertilization><Institution><Intervention><Intervention Strategies><LAV-HTLV-III><Leadership><Licensure><Lymphadenopathy-Associated Virus><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><MTB vaccine><Maps><Metabolic><Metagenomics><Mission><Missouri><Modeling><Molecular><Molecular Biology><Molecular Immunology><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><NIAID><National Institute of Allergy and Infectious Disease><Neurologic><Neurological><Participant><Passive Immunization><People at risk><Performance><Persons><Persons at risk><Pharmacogenomics><Phase><Play><Populations at Risk><Position><Positioning Attribute><PrEP><Prevalence><Preventative intervention><Prevention><Prevention Research><Productivity><Protocol><Protocols documentation><Records><Research><Research Design><Resistance><Risk><Role><Rural><Science><Severities><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Social Behavior><Study Type><System><TB infection><TB vaccine><Techniques><Technology><Tennessee><Testing><Therapeutic><Tuberculosis><Tuberculosis Vaccines><United States><Universities><University Medical Centers><Vaccine for TB><Vaccine for Tuberculosis><Vaccines><Venereal Diseases><Venereal Disorders><Venereal Infections><Viral Burden><Viral Diseases><Viral Load><Viral Load result><Viral hepatitis><Virus Diseases><Virus-HIV><Washington><acquired immunodeficiency syndrome clinical trial group><anti-TB vaccine><antibody titering><antiretroviral therapy><antiretroviral treatment><biologic><clinical research site><clinical site><co-morbid><co-morbidity><comorbidity><design><designing><developmental><diagnostic technologies><disseminated TB><disseminated tuberculosis><drug-sensitive><enroll><epidemiologic><epidemiological><hepatitis virus infection><host response><human genomics><human immunodeficiency virus vaccine><immune system response><immunoresponse><improved><infection due to Mycobacterium tuberculosis><intervention for prevention><interventional strategy><member><neutralizing antibody><new vaccines><next generation vaccines><novel><novel vaccines><opiate use disorder><opioid use disorder><pandemic><pandemic disease><participant enrollment><participant safety><passive vaccination><patient enrollment><pre-exposure prophylaxis><prevent><preventing><prevention intervention><preventional intervention strategy><preventive intervention><programs><recruit><resistant><response><sexually acquired infection><social role><sociobehavior><sociobehavioral><study design><subject safety><success><tuberculosis infection><tuberculous spondyloarthropathy><vaccine against M. tuberculosis><vaccine against Mtb><vaccine against Mycobacterium tuberculosis><vaccine against TB><vaccine against tuberculosis><vaccine candidate><vaccine candidates against tuberculosis><vaccine response><vaccine responsiveness><vaccine-induced response><viral infection><virus infection><virus-induced disease>