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Formulation and clinical translation of microneedles for vaccination in developing countries
Advisor:
Mark R. Prausnitz, PhD - School of Chemical and Biomolecular Engineering, Georgia Institute of Technology
Committee:
Julie A. Champion, Ph.D. - School of Chemical and Biomolecular Engineering, Georgia Institute of Technology
Jonathan S. Colton, Ph.D. - George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology
Krishnendu Roy, Ph.D. - Wallace H. Coulter Dept. of Biomedical Engineering, Georgia Institute of Technology
William C. Weldon, Ph.D. - Polio and Picornavirus Laboratory Branch, Centers for Disease Control and Prevention
Most vaccines are currently administered by healthcare personnel using a needle and syringe. This delivery method poses significant hurdles in vaccine delivery, especially in developing countries. It requires trained personnel to administer each dose, creates medical sharps waste that must be safely disposed of to prevent reuse and necessitates the need of cold chain for vaccine stability. Dissolving microneedle patches contain micron sized needles made out of water-soluble biodegradable polymers that dissolve in the skin to deliver the vaccine. They offer the simplicity of patch application and the possibility to mitigate the logistical and safety challenges associated with conventional hypodermic needles.
Polio eradication efforts have greatly reduced the effects of this disease, but significant challenges need to be overcome to achieve complete eradication of the disease. Much of the disease reduction in developing countries is made possible by the simplicity in the use of oral polio vaccine. Complete eradication will necessitate the use of inactivated polio vaccine, which is currently administered by an intramuscular injection. In addition, human rabies is eliminated in most developed countries by employing control measures of vaccinations in animals. Dogs account for nearly all human rabies infections in developing countries and vaccinations are difficult to employ in animals due to the need of a needle and syringe and the cost of administration. We propose that dissolving microneedle patches can be a substitute to needle and syringe injection in both of these vaccination scenarios.
The overall goal of this project is to develop and study dissolving microneedle patches to further clinical translation of this technology in the context of vaccinations in developing countries. The central hypothesis is that polio and rabies vaccines can be stabilized in a dissolving microneedle patch and be at least as immunogenic as conventional needle and syringe, while enabling simple administration. This will be assessed by (i) determining parameters for reliable patch insertion in a human study (ii) engineering patches for polio vaccination and evaluating immune response in small animal and non-human primate model and (iii) engineering patches for veterinary rabies vaccination and evaluating immune response in dogs.
