MILITARY HIV RESEARCH
Abstract
This PE maturates and demonstrates advanced technology of candidate human immunodeficiency virus (HIV) vaccines, prepares and conducts human clinical studies to assess safety and effectiveness of candidate HIV vaccines, conducts research to control HIV infection in military environments, protects the military blood supply from HIV, and protects military personnel from risks associated with the HIV infection. All HIV technology development activities are conducted in compliance with FDA regulations. FDA requires thorough testing in animal models (preclinical testing) to ensure safety and effectiveness prior to approving controlled clinical evaluation of drugs, vaccines, and medical devices in humans. Normally, clinical trials are conducted in three phases to prove safety and effectiveness of the drug, vaccine, and device for the targeted disease or condition. An increasing number of test subjects are used in each subsequent phase. All results are submitted to FDA for evaluation to ultimately obtain approval (licensure) for routine medical use. This program is jointly managed through an Interagency Agreement by the U.S. Army Medical Research and Materiel Command (USAMRMC), the National Institutes of Health, and the National Institute of Allergy and Infectious Diseases (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). 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, and NMRC, Silver Spring, MD, and its overseas laboratories. The Henry M. Jackson Foundation, located in Bethesda, MD, provides support for FDA testing and other research under cooperative agreement.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2015
- Source ID
- 0603105A_3_2040_PB_2015
- Change Summary Explanation
- Service Agency Name
- Army
Entities
Organizations
- United States Army
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