SILVER SPRING, Md. (NNS) -- Researchers from the Naval Medical Research Center's (NMRC) Infectious Diseases Directorate announced Dec. 2, they are ready to begin a Phase-1 dengue vaccine clinical trial in Silver Spring, Md. this month.
The announcement comes at a critical time with recent outbreaks around the world, including in the Federated States of Micronesia and the Marshall Islands, where Navy Medicine personnel are currently on the ground assisting the CDC and the World Health Organization with the occurrence there.
"The increase in dengue endemicity worldwide raises the likelihood of multiple exposures for deployed U.S. military personnel, potentially increasing their risk for developing the more severe forms of the disease - dengue hemorrhagic fever and dengue shock syndrome," said Lt. Cmdr. Janine R. Danko, principle investigator on the study and an Internist and Infectious Diseases Subspecialist. "The goal of our dengue vaccine program is to develop a safe and effective vaccine that protects against dengue."
Transmitted by the Aedes aegypti mosquito, dengue is one of the most common viral infections deployed personnel can acquire when stationed in tropical areas of the world. Dengue infection can be incapacitating and harmful to DoD missions and no treatment is available to prevent infection; a vaccine is critically needed.
The NMRC team has been preparing for this study for the past two years. The core team incorporates NMRC scientists and physicians, physicians from the Walter Reed Army Institute of Research, and industry partners. The FDA's positive review of the NMRC's Investigational New Drug (IND) application for the vaccine permits the research team to move forward to the next stage in the vaccine development process.
An FDA phase 1 trial is a clinical study in a small number of volunteers to evaluate the safety of a new vaccine. The FDA will provide oversight ensuring the study will produce useful information to assess the safety and efficacy of the vaccine.
"Developing a dengue vaccine is a top priority for military infectious disease research," said Capt. Kevin R. Porter, director, NMRC Infectious Diseases Directorate. "We are using a vaccine that has shown effectiveness in recent pre-clinical studies. The upcoming Phase 1 clinical trial of this vaccine approach is a critical step toward meeting the need for a tetravalent dengue vaccine to protect deployed military forces against dengue fever."
This 12-month study includes forty volunteers who will be assigned to three dose groups and followed through several visits and laboratory assessments with the study team physicians. The research team intends to compare the immune responses between the three groups.
"Our vaccine is DNA-based and was created and patented by several scientists in our department. The advantages of DNA-based vaccines include their simplicity of construction and modification, their relatively low cost of production, stability at room temperature, and their safety based on published data," said Danko. "We're excited to start this clinical trial and are hopeful for promising data to lead us to a larger and dose-finding Phase II trial."
Navy Medicine is a global healthcare network of 63,000 Navy medical personnel around the world who provide high quality health care to more than one million eligible beneficiaries. Navy Medicine personnel deploy with Sailors and Marines worldwide, providing critical mission support aboard ship, in the air, under the sea and on the battlefield.