Med Protect Agnst Hiv
Abstract
This project funds research to develop candidate HIV vaccines, to assess their safety and effectiveness in human subjects, and to protect the military personnel from risks associated with HIV infection. In addition, it is designed to find ways to protect the blood supply from contamination with HIV virus. All HIV technology development is conducted in compliance with U.S. Food and Drug Administration (FDA) regulations. Evaluations in human subjects are conducted to demonstrate safety and effectiveness of candidate vaccines, as required by FDA regulation. Studies are conducted stepwise: first, to prove safety; second, to demonstrate the desired effectiveness of the drug, vaccine, or device for the targeted disease or condition in a small study; and third, to demonstrate effectiveness in large, diverse human population trials. All results are submitted to the FDA for evaluation to ultimately obtain approval (licensure) for medical use. This project supports studies for effectiveness testing on small study groups after which they transition to the next phase of development for completion of effectiveness testing in larger populations. This program is jointly managed through an Interagency Agreement by USAMRMC and NIAID. This project contains no duplication with any effort within the Military Departments or other government organizations. Work is fully coordinated with work funded in program element PE 0602787A, project 873 (HIV Exploratory Research), and are further matured under PE 0603807A, project 811. The cited work is consistent with the Assistant Secretary of Defense, Research and Engineering Science and Technology, focus areas and the Army Modernization Strategy. Work in this PE is performed by WRAIR, Silver Spring, MD, and its overseas laboratories. Significant work is conducted under a cooperative agreement with the Henry M. Jackson Foundation, Bethesda, MD.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2014
- Source ID
- H29_0603105A_3_2040_PB_2014
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