Military HIV Research Program (Army)
Abstract
This project funds research to develop candidate Human Immunodeficiency Virus (HIV) vaccines, to assess their safety and effectiveness in human subjects, and to protect the military personnel from risks associated with HIV infection. 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 vaccine in a small study (to demonstrate early proof-of-concept); and third, to demonstrate effectiveness in large, diverse human population clinical 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 advanced developers for completion of effectiveness testing in larger populations. This program is jointly managed through an Interagency Agreement between the U.S. Army Medical Research and Materiel Command and the National Institute of Allergy and Infectious Diseases. This project contains no duplication with any effort within the Military Departments or other government organizations. The cited work is also consistent with the Assistant Secretary of Defense, Research and Engineering Science and Technology focus areas.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2020
- Source ID
- 448A_0603115DHA_2_0130_PB_2020
Related Documents
- Root: Medical Technology Development
- Child Accomplishment: Military HIV Research Program