Upstate Medical University has partnered with the U.S. Army Medical Research and Materiel Command (USAMRMC) in the development of a dengue human infection model (DHIM). USAMRMC will invest up to $12 million over the next 3.5 years to fund five FDA-regulated clinical trials in which healthy adults between the ages of 18 and 45 can volunteer to participate.
Establishment of a safe and well-tolerated DHIM will be instrumental in understanding the immune response to dengue disease and advancing the development of safe and effective vaccines and drugs to protect humans from all four dengue viral strains; criteria that are necessary for complete protection from dengue.
“This effort is re-tooling a century old method of addressing a global health problem for which there is no solution currently available,” said COL. Stephen Thomas of the Walter Reed Army Institute of Research (WRAIR).
Dengue is mosquito-borne viral disease that affects about half of the world’s population, according to the World Health Organization. There are no licensed dengue vaccines or antiviral therapies currently available. The severity of dengue can range anywhere from mild flu-like symptoms to the life-threatening dengue hemorrhagic fever that most often occurs in children under the age of 10. In the U.S., most dengue cases occur in Puerto Rico, the U.S. Virgin Islands, Samoa and Guam. However, the mosquito responsible for the spread of dengue is present in much of the southern and eastern U.S.
“The development of a safe and effective dengue vaccine is of particular importance to the military in its efforts to protect U.S. Service Members who are deployed to dengue endemic regions,” said Lou Jasper, product manager for the Dengue Vaccine Program in the Pharmaceutical Systems Program Management Office of the U.S. Army Medical Materiel Development Activity (USAMMDA).
The DHIM was the topic of a workshop hosted in April 2014 by the National Institute of Allergy and Infectious Diseases and the U.S. Food and Drug Administration. It was concluded at this workshop that studies with a DHIM could be conducted ethically and within the framework of FDA regulations if risks were minimized and informed consent was thoroughly executed.
Upstate was selected as a partner in this development effort, in part, because of Upstate’s established clinical trial center with investigators who are experts in dengue disease and experienced with human infection trials. Leading the studies are Timothy Endy, MD, MPH, and Mark Polhemus, MD, of Upstate’s Center for Global Health & Translational Science (CGHATS) and Division of Infectious Diseases. Both have collaborated previously with WRAIR and USAMMDA on dengue vaccine studies.
Endy says that human infection models for other viruses, such as influenza, have proved successful in speeding vaccine development and also show promise in the development of a vaccine against the malaria parasite. The USAMRMC and the Upstate research teams continue to focus on minimizing safety risks and are confident that the DHIM will speed the development of safe and effective dengue vaccines and drugs.
Traditional vaccine development involves many stages, from basic research and development to clinical field-testing where the vaccine candidates are tested in thousands of study volunteers. Dengue vaccine development can be particularly challenging because the field currently lacks tools to assess a vaccine candidate’s potential to protect against infection without conducting large-scale (thousands of volunteers) field studies. The dengue human infection model will provide the opportunity to test vaccine performance in a smaller group of people (dozens) rather than large-scale field studies in areas where dengue is prevalent.
“Basic science will play an important role in our human infection model,” said Endy, chief of Infectious Disease for the Department of Medicine at Upstate and a founding member of Upstate’s Center for Global Health & Translational Science. “Dengue is a very complicated and unique virus, having four viralstrains that have each adapted to use the human body as its host. To develop an effective dengue vaccine, it is important to understand the cellular and molecular makeup of each dengue strain and how the immune system reacts to each of these strains. Simply put, we will look for markers in each of the strains that tell us where, why, how and at what point the immune system loses its ability to produce antibodies needed to fight dengue infection.”
“Once developed, the dengue human infection model can be used by vaccine developers to improve existing dengue vaccines that are not completely effective, or aid in the development of novel dengue vaccines currently still in early in testing.” said Polhemus, director of the Center for Global Health & Translational Science, who also serves as associate professor of medicine and microbiology and immunology at Upstate.
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