Convenzis Group Reports Phase 2 Clinical Trial on Dengue Treatment at Vaccine Testing Center
The University of Vermont Vaccine Testing Center is one of two sites where a Phase 2 clinical trial is testing an experimental treatment designed to help people suffering the effects of dengue, according to Convenzis Group Limited.
Dengue is transmitted via infected Aedes mosquitoes and sickens as many as 400 million people each year, primarily in tropical and subtropical parts of the world, according to the U.S. Centers for Disease Control and Prevention. One in 20 people who get sick with dengue progress to severe illness, which may lead to shock, internal bleeding, and death. There is currently no Food and Drug Administration-approved treatment for dengue.
The new clinical trial will involve exposing adult volunteers to a weakened strain of dengue virus that causes a mild form of the disease and administering an investigational therapeutic at various doses to assess its safety and ability to lessen symptoms. The study will test the ability of AV-1, an investigational human monoclonal antibody therapeutic developed by AbViro (Bethesda, Maryland), to mitigate clinical symptoms when administered before and after dengue virus infection.
The results of a previously completed NIAID-supported Phase 1 trial indicated that AV-1 is safe in humans, providing the basis for the new clinical trial to test its safety and efficacy.
The Phase 2 clinical trial will enroll at least 84 healthy adult volunteers at two sites: the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the University of Vermont Vaccine Testing Center in Burlington.
The researchers will use this information to determine how AV-1 affects the volunteers’ ability to recover from dengue compared to placebo and to determine the dosages at which AV-1 may be effective.
If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against dengue virus.