Inviragen, Inc. today announced the initiation of the second stage of an ongoing Phase 2, randomized, double-blind, placebo-controlled study of DENVax™, the Company's investigational dengue vaccine. An independent data and safety monitoring board (DSMB) evaluated the preliminary safety data from the first stage of the Phase 2 trial, in which individuals in multiple age groups received either DENVax vaccine or placebo. Upon the review and the recommendation of the DSMB, Inviragen is advancing DENVax into the second stage of this clinical trial. In this second stage, DENVax will be tested for safety and immunogenicity in approximately 200 additional children aged 18 months to 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," said Dr. Dan Stinchcomb, CEO of Inviragen. "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 added, "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. 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."