IND BASE ID VACC&DRUG
Abstract
This project matures and demonstrates US Food and Drug Administration (FDA) regulated medical countermeasures such as drugs, vaccines, and diagnostic systems to naturally occurring infectious diseases that are threats to US military deployed forces. The focus of the program is on prevention, diagnosis, and treatment of diseases that can adversely impact military mobilization, deployment, and operational effectiveness. Prior to licensure of a new drug or vaccine to treat or prevent disease, the FDA requires testing in human subjects. Studies are conducted stepwise: first to prove the product is safe in humans, second to demonstrate the desired effectiveness and optimal dosage in a small study, and third to demonstrate effectiveness in large, diverse human populations. All test results are submitted to the FDA for evaluation to ultimately obtain approval (licensure) for medical use. This project supports studies for safety and effectiveness testing on small study groups after which they transition to the next phase of development for completion of studies in larger populations. The project also supports testing of personal protective measures that can reduce disease transmission from biting insects and other vectors to include products such as repellents and insecticides which are regulated by the U. S. Environmental Protection Agency (EPA). Research conducted in this project focuses on the following five areas: (1) Drugs to Prevent/Treat Parasitic (symbiotic relationship between two organisms) Diseases (2) Vaccines for Preventing Malaria (3) Bacterial Threats (4) Viral Threats (5) Diagnostics and Disease Transmission Control Research is conducted in compliance with FDA regulations for medical products for human use and EPA-regulations for insect control products that impact humans or the environment (e.g., repellents and insecticides). Work is managed by the Walter Reed Institute of Research (WRAIR), US Army Medical Institute of Infectious Disease (USAMRIID), and coordinated with Naval Medical Research Center (NMRC). The Army is responsible for programming and funding all DoD naturally occurring infectious disease research requirements, thereby precluding duplication of effort within the Military Departments. Promising medical countermeasures identified in this project are further matured under PE 0603807A, project 808. 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 project is performed by the Walter Reed Army Institute of Research, Silver Spring, MD, and its overseas laboratories; the US Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD; and the Naval Medical Research Center, Silver Spring, MD, and its overseas laboratories.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2012
- Source ID
- 810_0603002A_3_2040_PB_2012
Related Documents
- Root: MEDICAL ADVANCED TECHNOLOGY
- Child Accomplishment: Drugs to Prevent/Treat Parasitic Diseases
- Child Accomplishment: Vaccines for Prevention of Malaria
- Child Accomplishment: Bacterial Threats
- Child Accomplishment: Viral Threats Research
- Child Accomplishment: Diagnostics and Disease Transmission Control