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
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Walsh, Stephen R; Moodie, Zoe; Fiore-Gartland, Andrew J et al. (2016) Vaccination With Heterologous HIV-1 Envelope Sequences and Heterologous Adenovirus Vectors Increases T-Cell Responses to Conserved Regions: HVTN 083. J Infect Dis 213:541-50
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Fiore-Gartland, Andrew; Manso, Bryce A; Friedrich, David P et al. (2016) Pooled-Peptide Epitope Mapping Strategies Are Efficient and Highly Sensitive: An Evaluation of Methods for Identifying Human T Cell Epitope Specificities in Large-Scale HIV Vaccine Efficacy Trials. PLoS One 11:e0147812
Moodley, Nishila; Gray, Glenda; Bertram, Melanie (2016) Projected economic evaluation of the national implementation of a hypothetical HIV vaccination program among adolescents in South Africa, 2012. BMC Public Health 16:330

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