As travelers in the United States prepare for another year of record-setting Dengue fever outbreaks, a human monoclonal antibody (mAb) candidate from a Bethesda, MD-based company may soon obtain U.S. FDA approval.
As of February 12, 2025, the National Institutes of Health and AbViro LLC phase IIa clinical trial is exposing healthy volunteers in Maryland and Vermont to a weakened strain of the Dengue virus. The study will compare three AV-1 dose levels in adults challenged with DENV-3, the most infectious Dengue virus strain.
This study launched in early January 2025 and is expected to be completed this Fall.
Currently, no approved Dengue vaccines or mAb are available in the U.S.
If successful, the AV1 vaccine candidate could become the first dengue fever treatment approved by the FDA. Previously, the Dengvaxia® vaccine was approved but has since been withdrawn from the U.S. market.
Furthermore, the market-leading second-generation vaccine, Qdenga, is not approved in the U.S.
National Institute of Allergy and Infectious Diseases director Jeanne Marrazzo commented in a media release, “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.”
While vaccines are designed to stimulate the body’s immune system for many years, mAbs provide rapid protection…
