NIH-Funded Clinical Trial Tests Experimental Dengue Treatment

The National Institutes of Health (NIH) is supporting a groundbreaking clinical trial aimed at developing a therapeutic for dengue, a mosquito-borne viral disease that affects up to 400 million people yearly worldwide. Specifically, the National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring this study, which involves exposing adult volunteers to a weakened form of the dengue virus and administering a novel treatment at varying doses to assess its safety and effectiveness.

Dengue: A Growing Global Threat

Dengue fever is transmitted by infected Aedes mosquitoes and is particularly prevalent in tropical and subtropical regions. Recent statistics show a significant surge in dengue cases in the Americas, with local transmission reported in several U.S. states, including Arizona, California, Florida, Hawaii, and Texas. Puerto Rico also reported almost 1,500 cases last year. While many people infected with dengue do not exhibit symptoms, those who do may experience severe headaches, body aches, nausea, vomiting, fever, and rash. The disease can progress to a severe form, causing shock, internal bleeding, and, in some cases, death.

Currently, there is no commercially available FDA-approved treatment specifically for dengue fever, making this study particularly crucial.

“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

Study Details and Objectives

The Phase 2 clinical trial will recruit at least 84 healthy adult volunteers from two research centers: the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore and the University of Vermont Vaccine Testing Center in Burlington. Participants will undergo initial screening and a physical examination before being randomly divided into two groups. One group will receive the investigational monoclonal antibody AV-1 a day before being challenged with a weakened strain of the dengue virus, while the other group will receive the treatment four days afterward.

Both groups will be further subdivided based on the dose of AV-1 they will receive: 100 mg, 300 mg, or 900 mg, administered through a 60-minute intravenous infusion. For each of the three dose levels, 12 participants will receive the investigational treatment, and two will receive a placebo.

Volunteers will either receive the attenuated dengue virus before or after the AV-1 dosing. Previous studies using this challenge virus have shown that most volunteers develop a rash and some mild symptoms such as joint and muscle pain or headache. However, none have progressed to dengue fever or severe dengue.

Future Prospects of the Research

Should the data from this trial indicate promising results, researchers may proceed with further clinical evaluations to assess the safety and efficacy of AV-1 against the dengue virus. This could potentially lead to the development of an FDA-approved treatment, offering much-needed relief to individuals affected by this debilitating disease.

For more information about the study, visit ClinicalTrials.gov and use the identifier NCT06799741 to find the detailed study page.