Formulation and clinical translation of microneedles for vaccination in developing countries

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Arya, Jaya
Prausnitz, Mark R.
Colton, Jonathan S.
Champion, Julie A.
Roy, Krishnendu
Weldon, William
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Most vaccines are currently administered by healthcare personnel using a needle and syringe, which poses significant hurdles especially in developing countries. We propose dissolving microneedle patches to be a suitable alternative to needle and syringe vaccination in developing countries. 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. The overall goal of this thesis was to develop dissolving microneedle patches to further clinical translation of this technology in the context of vaccinations in developing countries. We studied two specific scenarios, development of microneedle patches for rabies vaccination of dogs and assessment of dissolving microneedle patches in human subjects. The central hypothesis was that rabies vaccine can be stabilized in a dissolving microneedle patch and be at least as immunogenic as conventional needle and syringe while enabling simple administration and that dissolving microneedle patches could be easily administered without the need of an applicator, be well tolerated in the skin and preferred over needle and syringe administration. This was assessed by engineering patches for veterinary rabies vaccination and evaluating immune response in dogs and determining tolerability, usability and acceptability of placebo microneedle patches in human subjects. Altogether, the results from this thesis should further clinical translation of microneedles for vaccination in developing countries.
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