This proposal describes the organization of a comprehesive, multidisciplinary, international HIV Vaccine Trials Network (HVTN). Components of the HVTN include a Leadership Coordinating and Operations Center (L. Corey, PI;J.N.Wasserheit, Director), a Statistical and Data Management Center (S.G. Self, PI),and a Network Laboratory Program (M.J.McElrath, PI).The HVTN's mission is to provide an objective and transparent platform to evaluate candidate HIV vaccines for the prevention of HIV infection in adult and adolescent populations globally. To achieve this, the HVTN will perform safety, immunogenicity, and efficacy trials of candidate HIV vaccines and adjuvants;conduct head- to-head comparisons of candidate vaccines;develop laboratory and statistical approaches to define potential correlates of protection;design trials to estimate the effects of vaccines that reduce HIV viral set point on HIV transmission;conduct trials of candidate vaccines in special populations, such as adolescents and intravenous drug users;develop a community education program to enhance the enrollment and retention of populations at high risk for HIV acquisition;develop standardized risk reduction counseling methods;and collaborate with other NIH networks, federal agencies and non-governmental research organizations to advance the highest quality HIV vaccine research, with optimal efficiency and cost effectiveness. Relevance: The progression of the HIV epidemic, as well as the international, political, and economic toll, make a compelling case for an effective preventive HIV vaccine. While other prevention strategies offer important advances in slowing the rate of spread of HIV, the high incidence of asymptomatic persistently infected HIV-infected persons requires the development of an effective vaccine. In order to reduce the spread of this global pandemic a robust integrated laboratory and clinical trials network is a necessary driver of the HIV vaccine field.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI068614-07
Application #
8293167
Study Section
Special Emphasis Panel (ZAI1-TH-A (J1))
Program Officer
Renzullo, Philip O
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2012-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2012
Total Cost
$32,353,045
Indirect Cost
$10,617,225
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Godfrey, Catherine; Schouten, Jeffrey T; Swindells, Susan (2014) Implementation of HIV-related clinical research in the international setting. J Acquir Immune Defic Syndr 65 Suppl 1:S1-2
Arnold, Michael P; Andrasik, Michele; Landers, Stewart et al. (2014) Sources of racial/ethnic differences in awareness of HIV vaccine trials. Am J Public Health 104:e112-8
Andrasik, Michele Peake; Chandler, Christian; Powell, Borris et al. (2014) Bridging the divide: HIV prevention research and Black men who have sex with men. Am J Public Health 104:708-14
Goepfert, Paul A; Elizaga, Marnie L; Seaton, Kelly et al. (2014) Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 210:99-110
Godfrey, Catherine; Schouten, Jeffrey T (2014) Infection control best practices in clinical research in resource-limited settings. J Acquir Immune Defic Syndr 65 Suppl 1:S15-8
Usher, DaShawn; Frye, Victoria; Shinnick, Julianna et al. (2014) Recruitment by a geospatial networking application for research and practice: the New York City experience. J Acquir Immune Defic Syndr 67:e143-5
Finak, Greg; Jiang, Wenxin; Krouse, Kevin et al. (2014) High-throughput flow cytometry data normalization for clinical trials. Cytometry A 85:277-86
Godfrey, Catherine; Payton, Manizhe; Tasker, Sybil et al. (2014) Ensuring participant safety and trial integrity with clinical trials oversight. J Acquir Immune Defic Syndr 65 Suppl 1:S40-3
Gray, Glenda E; Moodie, Zoe; Metch, Barbara et al. (2014) Recombinant adenovirus type 5 HIV gag/pol/nef vaccine in South Africa: unblinded, long-term follow-up of the phase 2b HVTN 503/Phambili study. Lancet Infect Dis 14:388-96
Elizaga, Marnie L; Vasan, Sandhya; Marovich, Mary A et al. (2013) Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One 8:e54407

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