NIH-supported clinical
NIH-supported clinical trial to test experimental treatment for dengue
A clinical trial supported by the National Institutes of Health (NIH) is testing an experimental treatment designed to help people suffering the effects of dengue, a mosquito-borne viral disease. The study is supported by NIH's National Institute of Allergy and Infectious Diseases (NIAID), and 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.
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. In 2024, dengue cases surged to record levels in the Americas with local U.S. transmission reported in Arizona, California, Florida, Hawaii, and Texas. Dengue is endemic in Puerto Rico, which reported nearly 1,500 cases last year. Most people with dengue do not develop symptoms, but those who do commonly experience severe headache and body aches, nausea and vomiting, fever and rash. 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.
"When caring for a patient who is critically ill with dengue, healthcare providers have few options other than providing supportive care. We must find safe and effective therapeutics to provide much-needed relief to people suffering from dengue." Jeanne Marrazzo, M.D., M.P.H., NIAID Director
The new clinical trial 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.
If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against dengue virus. For more information about the study, visit ClinicalTrials.gov and search the identifier NCT06799741.
