NIH-Funded Clinical Trial Will Evaluate New Dengue Therapeutic
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An NIH-funded clinical trial is testing an experimental treatment designed to help people suffering the effects of dengue fever, a mosquito-borne viral disease. The study will involve exposing adult volunteers to a weakened strain of dengue virus 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. 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 progresses to severe illness. There is currently no FDA-approved treatment for dengue.
The new clinical trial will test the ability of AV-1, an investigational human monoclonal antibody therapeutic developed by AbViro, to mitigate clinical symptoms when administered before and after dengue virus infection.
The trial will enroll at least 84 healthy adult volunteers at two sites. Volunteers will be randomly assigned to one of two groups. One group will receive AV-1 one day prior to being challenged with a mild strain of dengue virus, and the other will receive AV-1 four days after being challenged with the dengue virus. Each group will be further subdivided to receive varying doses of AV-1, delivered in a 60-minute intravenous infusion. For each of the three dosage levels, 12 participants will receive the investigational monoclonal antibody, and two will receive a placebo.
Before or after AV-1 dosing, each volunteer will receive an injection of attenuated (weakened) dengue virus.
Volunteers will be carefully monitored by study staff in regular follow-up visits for at least 155 days. If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against dengue virus.