Vaccination Using Microneedle Patches: Design, Development and Clinical Translation

Abstract

While vaccines have dramatically reduced morbidity and mortality due to infectious diseases, there remain significant opportunities to improve vaccine immunogenicity and delivery. To address this need, we have developed microneedle patches, each containing an array of micron-sized needles on an adhesive backing, to be used for vaccine delivery to the skin. Our studies show that skin vaccination using microneedle patches is significantly more immunogenic than conventional intramuscular injection, as measured by improved humoral and cellular immune responses, protection against disease, longevity of immune responses, breadth of immunity and other measures. Microneedle patches can also improve vaccine delivery because they are easily and painlessly applied by pressing against the skin and, when using water-soluble microneedles, do not leave behind sharps waste. The patches are single-dose, do not require reconstitution, are easy to administer, have reduced size to simplify storage, transportation and waste disposal, and often have increased thermostability. Our studies have emphasized influenza vaccination, including many small-animal studies that have enabled a Phase 1 clinical trial currently under way. Additional studies have examined inactivated polio, measles and rubella vaccines in monkeys and a number of other vaccines in small animals. Translation of this technology into commercial development is occurring at a number of companies, including one that was founded by our team at Georgia Tech.