Throughout the record-setting Dengue fever outbreak in the Region of the Americas in 2024, most international travelers were unprotected when visiting at-risk countries such as Brazil, Costa Rica, and even Miami Breach.
Furthermore, once infected with this mosquito-transmitted viral disease, patients could not access innovative therapies.
To accelerate the approval of Dengue treatments, the U.S. National Institutes of Health (NIH) is testing an experimental treatment.
The phase 2 clinical study will involve exposing 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.
This NIH clinical trial will test the ability of AV-1, an investigational human monoclonal antibody (mAb) therapeutic developed by AbViro, to mitigate clinical symptoms when administered before and after dengue virus infection at Johns Hopkins Bloomberg School of Public Health Center for Immunization Research and the University of Vermont.
However, none of the volunteers will develop dengue fever or severe dengue during this study.
“When caring for a patient who is critically ill with dengue, healthcare providers have few options other than providing supportive care,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H., in a press release on February 11, 2025.
“We must find safe and effective therapeutics to provide much-needed relief to people suffering from dengue.”
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 the dengue virus.
The results of a previously completed 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.
Another Dengue mAb candidate, Dengushield (VIS513), is being evaluated in phase 2 clinical trials.
This mAb is a highly potent inhibitor of all four types of dengue viruses, both in vitro and in preclinical animal models. Dengushield was licensed to the Serum Institute of India Pvt. Ltd. for development.
Despite these potential innovations, during Spring Break 2025, preventing mosquito bites is the best tactic to avoid Dengue infection.














