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.
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.
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