SYRACUSE — Upstate Medical University’s Center for Global Health & Translational Science is looking for healthy men and women between the ages of 18 and 45 who want to be part of a study to develop a vaccine to combat the dengue (pronounced DENG-ee) virus. The initiative targets a “global public health concern,” Upstate […]
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SYRACUSE — Upstate Medical University’s Center for Global Health & Translational Science is looking for healthy men and women between the ages of 18 and 45 who want to be part of a study to develop a vaccine to combat the dengue (pronounced DENG-ee) virus.
The initiative targets a “global public health concern,” Upstate Medical said in a news release issued at its Nov. 23 announcement at Upstate’s Institute for Human Performance at 505 Irving Ave. in Syracuse.
The U.S. Army Medical Research and Materiel Command (USAMRMC) is working with the local medical school on the development of a dengue human-infection model.
Researchers will infect participants with a “mild form” of the dengue virus to develop symptoms, Dr. Timothy Endy, founding member of Upstate’s Center for Global Health & Translational Science, said during his remarks at the announcement.
The USAMRMC will invest up to $12 million over the next 3 1/2 years to pay for five clinical trials in which healthy adults can volunteer to participate.
Each volunteer will be financially compensated for the time associated with his or her six-month participation in the study, Upstate said.
The U.S. Food & Drug Administration, or FDA, will regulate the trials, the medical school added.
Researchers will screen the volunteers to ensure that they are medically fit, are dengue free, and have a healthy and uncompromised immune system.
For more information about the study, or to participate, contact the clinical-research coordinators at Upstate’s Center for Global Health & Translational Science at (315) 459-3031.
Upstate’s role
The U.S. Army selected Upstate 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, the medical school said.
The initiative will generate at least three or four new hires for clinical trials, Dr. Mark Polhemus, director of the Center for Global Health & Transitional Science, said when questioned about what effect the grant would have on employment.
The new hires will include a new investigator and a new clinical trialist as well, said Endy.
“A number of new hires will happen,” Endy added in responding to a reporter’s question.
About dengue
Dengue isn’t well known but it’s an “important” mosquito-borne viral disease that “truly is a global health problem,” said Endy.
“The severity of dengue can range from just having … a flu-like illness to the more severe form of dengue hemorrhagic fever where children and young adults are hospitalized in the intensive-care unit, mortality can be as high as 10 percent,” said Endy.
Dengue is caused by any one of four related viruses transmitted to humans through a bite from an Aedes aegypti mosquito, the type of mosquito that serves as a vector (carrier and transmitter) for the dengue virus, according to a fact sheet that Upstate Medical provided.
Dengue cases have been reported in Puerto Rico, the U.S. Virgin Islands, Samoa, Guam, Key West, Florida, and in the Hawaiian islands, said Endy.
Upstate has treated “several” patients admitted for acute dengue, including a traveler who had returned from Hawaii this past summer.
U.S. soldiers on active duty in places like Haiti and Somalia have been infected with dengue.
The Centers for Disease Control and Prevention has listed dengue as the leading cause of fever in returning travelers.
“Unfortunately, there is no licensed vaccine or [a] therapeutic against dengue and the delay for development of these types of therapeutics is largely because of a lack of an appropriate animal model to test vaccines and therapeutics,” said Endy.
Trial protocols
Upstate focuses the development of its protocols on safety of the individual volunteers, said Polhemus.
The SUNY institutional review boards, the FDA, and the human-research protection organization of the U.S. Department of Defense “extensively” review the protocols, he adds.
For this dengue human-infection model, Upstate will have extensive oversight during the conduct of the trial by the independent dengue-safety monitoring board. Members will be monitoring for any safety signals during the study.
“And we’ll have, additionally, an independent clinical monitor who’ll be monitoring the conduct of the study to ensure that all is in accordance with the protocol,” said
Polhemus.
Prior to enrollment, researchers will “thoroughly” screen volunteers with an “extensive” evaluation for their inclusion, exclusion criteria, and ability to be involved in the study.
“And once in the study, they’re closely monitored by our staff, both as outpatients and as soon as fever symptoms develop, as inpatients at our Community General Hospital where they’ll be closely monitored until resolution of their symptoms,” he added.
