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 #
5UM1AI068614-06
Application #
8088218
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
2011-06-01
Budget End
2012-05-31
Support Year
6
Fiscal Year
2011
Total Cost
$37,287,824
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Fong, Youyi; Shen, Xiaoying; Ashley, Vicki C et al. (2018) Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial. J Infect Dis 217:1280-1288
Thiam-Diouf, Arame; Metch, Barbara; Sharpe, Cameron et al. (2018) Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention. Vaccine 36:1235-1242
Janes, Holly; Corey, Lawrence; Ramjee, Gita et al. (2018) Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa. AIDS Res Hum Retroviruses 34:645-656
McGuire, Erin P; Fong, Youyi; Toote, Christopher et al. (2018) HIV-Exposed Infants Vaccinated with an MF59/Recombinant gp120 Vaccine Have Higher-Magnitude Anti-V1V2 IgG Responses than Adults Immunized with the Same Vaccine. J Virol 92:
Lennard, Katie; Dabee, Smritee; Barnabas, Shaun L et al. (2018) Microbial Composition Predicts Genital Tract Inflammation and Persistent Bacterial Vaginosis in South African Adolescent Females. Infect Immun 86:
Dietrich, Janan J; Lazarus, Erica; Andrasik, Michele et al. (2018) Mobile Phone Questionnaires for Sexual Risk Data Collection Among Young Women in Soweto, South Africa. AIDS Behav 22:2312-2321
Huang, Yunda; Karuna, Shelly; Carpp, Lindsay N et al. (2018) Modeling cumulative overall prevention efficacy for the VRC01 phase 2b efficacy trials. Hum Vaccin Immunother 14:2116-2127
Mngadi, Kathryn Therese; Maharaj, Bhavna; Duki, Yajna et al. (2018) Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc 7:e175
Bekker, Linda-Gail; Moodie, Zoe; Grunenberg, Nicole et al. (2018) Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV 5:e366-e378
de Montigny, Simon; Adamson, Blythe J S; Mâsse, Benoît R et al. (2018) Projected effectiveness and added value of HIV vaccination campaigns in South Africa: A modeling study. Sci Rep 8:6066

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