Needleless Intradermal Vaccine Delivery System Using Ultrasound

The objective of this proposal is to evaluate and optimize needlefree immunization on skin permeated with SonoPrep, an ultrasound-based skin permeation system. SonoPrep permeates the skin by creating pores in the stratum corneum, thus breaching its barrier function. This provides channels for vaccine delivery directly to the epidermis, where large populations of Langerhans cells reside. The Department of Defense has candidate vaccines against malaria, dengue, etc.in phase I or II clinical trials. Many of these vaccines though promising, lack complete protection and total immunogencity. Dendritic cells play an important role in orchestrating the host immune response. The ideal vaccine delivery system would require no needles, deliver the vaccine directly to immunomodulatory cells, be transportable, and easy to use. FDA 510K approval has been given to SonoPrep, that when delivered to the skin, creates micropores (75-100 µm) extended to the epidermis (20-35 µm deep). SonoPrep has been used effectively in humans to deliver Lidocaine topically. Due to the large population of Langerhans cells in the epidermis, it is hypothesized that immunity can be conferred if vaccines are delivered on ultrasound-permeated skin. This proposal seeks to evaluate this delivery system with the DoD vaccine candidates and evaluate the host immune response to this system as compared to conventional vaccine delivery. Phase I will compare safety and immune response of the ultrasonic delivery of a candidate vaccine as compared to conventional techniques. Phase II will consist of an expanded safety and immunogenicity study leading to phase III for vaccine efficacy and FDA 510 K approval.