This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Vaccine Trials Network (HVTN) is one of three applications comprising the Leadership Group of the HVTN. To address the overall scientific goal described in RFA-AI-12-012, the development of a safe and effective HIV vaccine, the HVTN SDMC scientific agenda includes the following aims:
Aim 1, to provide high quality secure data management and safety monitoring and to continually improve quality and efficiency by applying best data and clinical management practices, adhering to clinical data interchange standards, and implementing state-of-the-art technologies;
Aim 2, to design, monitor, and analyze pre-efficacy trials that evaluate the safety and immunogenicity of candidate HIV vaccine regimens;
Aim 3, to develop and implement tools and methods for data processing and analysis of immunological assays used for measuring vaccine immunogenicity;
Aim 4, to refine and implement novel Phase 2b test-of-concept and Phase 3 licensure trial designs with primary objective to assess vaccine efficacy to prevent HIV infection;
Aim 5, to refine and implement novel quantitative methods for assessing and developing immune correlates of protection against HIV infection and early biomarkers of disease progression for regimens showing efficacy;
Aim 6, in collaboration with other NIAD networks, to account for non-vaccine prevention modalities in meeting the objectives of Aims 2 through 5 and to co-conduct combination regimen trials;
Aim 7, to conduct clinical trials to assess monoclonal antibodies for HIV immunoprophylaxis and vaccines for TB and HCV. The SDMC has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. The systems we propose to use for data collection, management, monitoring and analysis are well-tested, in accordance with GCDMP, 21 CFR Part 11 and GCP, and will comply with CDISC Standards. In addition, SDMC statisticians and computational biologists will develop novel quantitative methodologies to increase efficiency, rigor, and scientific incisiveness of the proposed program of HIV vaccine trials.

Public Health Relevance

34 million people globally are estimated to be living with HIV, and 2.7 million new infections occur annually (2011 UNAIDS). Despite recent advances in biomedical interventions that reduce the risk of HIV acquisition, eliminating the pandemic will require a safe and effective HIV vaccine. Only through human clinical trials held to the highest scientific, ethical and regulatory standards will the goal of an HIV vaccine be realized.

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 #
5UM1AI068635-13
Application #
9605054
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Renzullo, Philip O
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2018-12-01
Budget End
2019-11-30
Support Year
13
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Yu, Tingting; Wu, Lang; Gilbert, Peter (2018) New approaches for censored longitudinal data in joint modelling of longitudinal and survival data, with application to HIV vaccine studies. Lifetime Data Anal :
Yates, Nicole L; deCamp, Allan C; Korber, Bette T et al. (2018) HIV-1 Envelope Glycoproteins from Diverse Clades Differentiate Antibody Responses and Durability among Vaccinees. J Virol 92:
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
Fong, Youyi; Huang, Ying; Lemos, Maria P et al. (2018) Rank-based two-sample tests for paired data with missing values. Biostatistics 19:281-294
Reeves, Daniel B; Duke, Elizabeth R; Wagner, Thor A et al. (2018) A majority of HIV persistence during antiretroviral therapy is due to infected cell proliferation. Nat Commun 9:4811
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
Benkeser, David; Carone, Marco; Gilbert, Peter B (2018) Improved estimation of the cumulative incidence of rare outcomes. Stat Med 37:280-293
Lee, Unkyung; Sun, Yanqing; Scheike, Thomas H et al. (2018) Analysis of Generalized Semiparametric Regression Models for Cumulative Incidence Functions with Missing Covariates. Comput Stat Data Anal 122:59-79
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
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

Showing the most recent 10 out of 167 publications