MILITARY HIV RESEARCH
Abstract
This program element (PE) matures and demonstrates advanced technology of candidate human immunodeficiency virus (HIV) vaccines, prepares and conducts human clinical studies to assess safety and efficacy 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 US Food and Drug Administration (FDA) regulations. FDA requires thorough testing in animal models (preclinical testing) to ensure safety and efficacy 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 US Army Medical Research and Materiel Command (MRMC), 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 Director, Defense Research and Engineering Strategic Plan, the Army Modernization Strategy, and the Army Science and Technology Master Plan. Work in this PE is performed by the Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, and its overseas laboratories; and the Naval Medical Research Center (NMRC), Silver Spring, MD, and its overseas laboratories. The Henry M. Jackson Foundation, located in Rockville, MD provides support for FDA testing and other research under cooperative agreement.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2012
- Source ID
- 0603105A_3_2040_PB_2012
- Change Summary Explanation
- Service Agency Name
- Army
Entities
Organizations
- United States Army
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