Ind Base Id Vacc&Drug
Abstract
This Project maturates and demonstrates United States (U.S.) Food and Drug Administration (FDA)-regulated medical countermeasures such as drugs, vaccines, and diagnostic (identification of the nature and cause of a particular disease) systems to naturally occurring infectious diseases that are threats to deployed United States military forces. The focus of the Project 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 (amount to be administered) 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 the studies for safety and effectiveness testing on small study groups after which they transition to the next phase of development for completion of expanded safety and initial studies for effectiveness in larger populations. If success is achieved for a product in this Project, the effort will transition into Advanced Development. The Project also supports testing of personal protective measures that can reduce disease transmission from arthropods to include products such as repellents and insecticides, which are regulated by the Environmental Protection Agency (EPA). Research conducted in this Project focuses on the following four areas: (1)Prevention/Treatment of Parasitic (organism living in or on another organism) Diseases (2)Bacterial Disease Threats (diseases caused by bacteria) (3)Viral Disease Threats (diseases caused by viruses) (4)Diagnostic Systems and Vector Identification and 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 United States Army Medical Research and Materiel Command (USAMRMC) in coordination with the Naval Medical Research Center (NMRC). The Army is responsible for programming and funding all Department of Defense (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 Program Element 0603807A, Project 808. The cited work is consistent with the Assistant Secretary of Defense, Research and Engineering Science and Technology, focus areas and the Army Modernization Strategy. Efforts in this Project support the Soldier portfolio and the principal area of Military Relevant Infectious Diseases.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2019
- Source ID
- 810_0603002A_3_2040_PB_2019
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