In the aftermath of global terrorist actions, the possibility that biological agents can be used as weapons of terror has been recognized. Influenza has been identified as a high priority organism with bioterrorism potential. In addition, the rise of respiratory diseases and periodic natural pandemics caused by influenza strains, with altered antigenic specificity, cause great concern. Millions of people world wide are infected by influenza, with high mortality and morbidity outcomes. In the US, 20% of the population may develop influenza annually resulting in the death of 20,000 per year many of these over the age of 65 or suffering from underlying diseases. The most widely used method to prevent infection, is intramuscular vaccination with a vaccine mixture using a syringe and plunger. However, fear of needles, associated pain and discomfort and limited access result in poor compliance. The development of a novel, cost-effective, self-administration device will allow rapid distribution and safer use, improving the chances of survival and providing a level of protection against microbiological agents. This application proposes the development, calibration and clinical validation of an advanced prototype based on a proprietary device for an auto-injector with an automatically retractable needle. This platform technology for rapid self-injection using pre-filled cartridges can be adapted for use with other injectable drugs and vaccines. ? The specific aims of this Phase I SBIR Biodefense proposal are to develop a self-administration injection device for influenza vaccine to combat and prepare for biodefense as well as having commercial value. The device will be calibrated and validated for untrained personnel use, providing an evaluation of the differences between subcutaneous and intramuscular vaccination. The clinical studies are designed to demonstrate that self-injection device can be used effectively and safely by the general public using a total of 300 subjects varying from 18 - 70 years of age. A trained nurse will use the traditional method performing the injections in the deltoid muscle of the arm. Subjects will self-administer the vaccine either subcutaneously or intramuscularly using auto-injectors designed for these two applications. The hypotheses will test that the novel self-injector will be bioequivalent in effectiveness to that given by a trained nurse. Successful conclusion of these milestones will lead to commercialization and manufacture of the device and FDA approval. ? ?
