The U.S. Army Medical Research Acquisition Activity (USAMRAA) has issued a solicitation focused on accelerating development of a dengue human infection model (DHIM).
The DHIM aims to safely and reproducibly create uncomplicated dengue infections in human volunteers using live, attenuated, well-characterized dengue virus (DENV) challenge material. The DHIM will be achieved when each of the four DENV challenge strains (serotypes 1-4) is characterized via Food and Drug Administration (FDA) Phase 1 clinical studies.
Dengue viruses (DENVs) are flaviviruses transmitted by infected mosquitoes that cause a clinical spectrum of human disease ranging from mild viremia to severe intravascular volume depletion and hemorrhage. Efforts are underway worldwide to develop safe, effective anti-viral drugs and vaccines against Dengue but significant technical barriers impede progress including the immunologic complexity of the disease and lack of a correlate of protection or validated animal models of disease. Consequently, medical product developers must rely primarily on the conduct of large clinical studies in endemic regions (typically in pediatric volunteers) at great expense and financial risk.
The DHIM represents an opportunity to reduce overall risk during clinical development. For example, medical product developers may leverage the DHIM to explore pre-infection immune profiles and correlate results with post-experimental infection clinical outcomes across a range of conditions and scenarios. It also may clarify how human humoral- and/or cellular-immune responses are associated with protection against DENV disease progression and, therefore, reduce the size and scope of future clinical trials and facilitate an improved use of existing laboratory animal models. In the long term, the DHIM could become a validated tool recognized by the FDA to fill gaps in medical product efficacy data from DENV field studies.
This is a Medical Technology Enterprise Consortium (MTEC) solicitation. MTEC is a nonprofit organization designed to conduct advanced applied research for prototype development addressing a range of military capability needs. Please visit the MTEC membership page to learn how to join.
MTEC anticipates that a single award will be made to a qualified team composed of multiple investigators or institutions responsible for partnering to accomplish all tasks.
Further details are available via FBO.gov. The response deadline is Mar 13, 2017 12:00 pm Eastern.
