Inviragen advances to next stage of dengue vaccine study
The second stage was started after an independent data and safety monitoring board evaluated preliminary data from the study. During the second stage, Inviragen will test DENVax for safety and immunogenicity in approximately 200 children between the ages of 18 months and 11 years.
"The completion of the first stage of this Phase 2 study is an important milestone for Inviragen, as it represents the first comprehensive safety evaluation of the vaccine in individuals of various ages who live in dengue endemic areas," Inviragen CEO Dr. Dan Stinchcomb said. "The DSMB determined that the first dose of the vaccine is well tolerated in adults, adolescents and children, some of whom were pre-exposed to dengue viruses."
Dr. Gilad Gordon, Inviragen's chief medical officer, was pleased with the results of the first stage.
"In completed and on-going Phase 1 and 2 studies, we have enrolled over 400 subjects in DENVax clinical trials and more than 300 have received the vaccine," Gordon said. "Overall, DENVax has been very well tolerated with mostly mild adverse events. The second part of this Phase 2 clinical trial will yield additional insight about the vaccine's safety and immunogenicity in children as young as 18 months and will set the stage for future vaccine efficacy studies."