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--Cooperative Agreements (U01)
Project #
5U01AI068614-02
Application #
7254104
Study Section
Special Emphasis Panel (ZAI1-TH-A (J1))
Program Officer
Renzullo, Philip O
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2007-06-01
Budget End
2008-05-31
Support Year
2
Fiscal Year
2007
Total Cost
$41,690,531
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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Leitman, Ellen M; Hurst, Jacob; Mori, Masahiko et al. (2016) Lower Viral Loads and Slower CD4+ T-Cell Count Decline in MRKAd5 HIV-1 Vaccinees Expressing Disease-Susceptible HLA-B*58:02. J Infect Dis 214:379-89
Deschamps, Marie M; Metch, Barbara; Morgan, Cecilia A et al. (2016) Feasibility of Identifying a Female Sex Worker Cohort at High Risk of HIV Infection in the Caribbean for HIV Vaccine Efficacy Trials: Longitudinal Results of HVTN 907. J Acquir Immune Defic Syndr 71:70-7
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Koblin, Beryl A; Grant, Shannon; Frye, Victoria et al. (2015) HIV Sexual Risk and Syndemics among Women in Three Urban Areas in the United States: Analysis from HVTN 906. J Urban Health 92:572-83
Anderson, Albert M; Harezlak, Jaroslaw; Bharti, Ajay et al. (2015) Plasma and Cerebrospinal Fluid Biomarkers Predict Cerebral Injury in HIV-Infected Individuals on Stable Combination Antiretroviral Therapy. J Acquir Immune Defic Syndr 69:29-35
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Sopher, Carrie J; Adamson, Blythe Jane S; Andrasik, Michele P et al. (2015) Enhancing diversity in the public health research workforce: the research and mentorship program for future HIV vaccine scientists. Am J Public Health 105:823-30
Gray, Glenda E; Corey, Lawrence (2015) Reevaluating HIV vaccine clinical trials policy for infants. J Infect Dis 211:501-3
Adamson, Blythe J S; Fuchs, Jonathan D; Sopher, Carrie J et al. (2015) A new model for catalyzing translational science: the early stage investigator mentored research scholar program in HIV vaccines. Clin Transl Sci 8:166-8

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