The trial examined three doses of the DNA influenza vaccine (one, two and four micrograms), in 12 volunteers per arm, making 36 volunteers in total. Each was administered as a single dose to healthy adult volunteers. The immune response was assessed according to the criteria laid down by the Committee for Proprietary Medicinal Products (CPMP) for the approval of annual flu vaccines in the European Union. All three doses passed the CPMP criteria at 56 days and the maximum dose (four micrograms) passed the criteria at 21 days and was well tolerated. At the maximum dose (four micrograms) 100 percent of the subjects achieved a seroprotective level of antibodies demonstrating that this DNA vaccine is a viable candidate for further trials to develop a vaccine against influenza or pandemic flu.
Dr. Clive Dix, CEO of PowderMed commented: "We are very encouraged by this positive clinical data generated with PowderMed technology. I am convinced that a PowderMed DNA flu vaccine could become a viable solution for the current threat from pandemic flu."
This DNA influenza vaccine can be readily commercialized using PowderMed's proprietary PowderJect(TM) Particle Mediated Epidermal Delivery (PMED(TM)) technology. DNA vaccines using PMED are highly versatile in that they rely on powdered DNA and can be stored at room temperature and have much longer shelf-lives than traditional vaccines.Source: PowderMed Ltd.