Breakthrough Clinical Trial for Dengue Fever Treatment Begins, Aiming for Effective Relief

In a significant advancement in the fight against dengue fever, a clinical trial backed by the National Institutes of Health (NIH) has commenced to evaluate an experimental treatment. This trial, supported by the NIH's National Institute of Allergy and Infectious Diseases (NIAID), aims to provide relief for millions suffering from this debilitating mosquito-borne viral disease, which affects approximately 400 million people annually across tropical and subtropical regions. Dengue fever, transmitted through the bites of infected Aedes mosquitoes, has seen an alarming rise in cases, particularly in the Americas. In 2024, the region experienced an unprecedented surge, with local transmissions reported in states such as Arizona, California, Florida, Hawaii, and Texas. Puerto Rico, being endemic to the disease, reported nearly 1,500 cases last year alone. While many infected individuals remain asymptomatic, those who do exhibit symptoms often endure severe headaches, body aches, fever, nausea, vomiting, and rashes. Alarmingly, one in 20 cases can escalate to severe illness, potentially leading to shock, internal bleeding, or even death. Currently, there are no FDA-approved treatments available for this viral infection, highlighting the urgent need for effective therapeutic options. Dr. Jeanne Marrazzo, NIAID Director, emphasized the pressing requirement for safe and effective treatments, stating, "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." The clinical trial will evaluate the investigational human monoclonal antibody therapeutic known as AV-1, developed by AbViro based in Bethesda, Maryland. Building on the favorable results of a previous Phase 1 trial, which established the safety of AV-1 in humans, researchers are now focused on assessing its effectiveness in alleviating clinical symptoms when administered before and after dengue virus exposure. At least 84 healthy adult volunteers will be enrolled in this Phase 2 clinical trial, taking place at 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 an initial screening and physical examination before being randomly assigned to one of two groups. One group will receive AV-1 one day prior to being exposed to a mild strain of the dengue virus, while the other group will receive the treatment four days post-exposure. Each group will be further divided to receive varying doses of AV-1—100 mg, 300 mg, or 900 mg—delivered through a 60-minute intravenous infusion. Alongside AV-1 dosing, participants will be injected with an attenuated strain of the dengue virus, which has led to mild symptoms in previous trials but not severe illness. Throughout the study, volunteers will be closely monitored for a minimum of 155 days, allowing researchers to document their immune responses, the rate of viral clearance from their systems, and any symptoms they may experience. This data will be pivotal in evaluating the therapeutic efficacy of AV-1 compared to a placebo and identifying the optimal dosages for potential therapeutic use. Should the trial yield promising outcomes, researchers may further pursue additional evaluations of AV-1's safety and efficacy against dengue virus, paving the way for much-needed treatment options for those affected by this growing global health threat. For those interested in more information about the study, additional details are available at ClinicalTrials.gov under the identifier NCT06799741.