VaxInnate Corp., a biotechnology company creating a novel vaccine technology platform, recently announced that it has started a double-blind, randomized, active comparator controlled Phase 2 study for a quadrivalent seasonal influenza vaccine candidate.
The study’s active comparator is Fluzone Quadrivalent, is a vaccine on the market. The office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), and Department of Health and Human Service (HHS) is fully funding the clinical trial according to a contract.
The vaccine, VAX2012Q, will be tested for its efficiency and safety. The study involves 459 healthy adults between the ages of 18 and 64. They will be based at six sites within the U.S., and participants will blindly receive one dose of VAX2012Q in 2 micrograms or 3 micrograms per component doses, or else they will receive a 15 micrograms per component dose of the Fluzone Quadrivalent vaccine. The researchers will then analyze the immune response of the subjects to the four components of VAX2012Q.
"We believe our proprietary recombinant vaccine production technology offers significant benefits over traditional manufacturing methods, including reliability and cost effectiveness," VaxInnate CEO and President Wayne Pisano said. "In addition, our technology also has the important benefit of speed, which can be essential when reacting to unexpected strain drifts, as we witnessed earlier in 2015. The initiation of this Phase 2 study represents another important milestone on our path to commercialization, and we look forward to seeing top-line results later this year."