Development of an IRV Microneedle Patch

Each year hundreds of thousands of children die of diarrheal disease caused by rotavirus Although rotavirus vaccination has resulted in an decrease in severe rotavirus related hospitalizations since its introduction current oral live rotavirus vaccines are not as effective in some low income countries as they are in industrialized countries and have been associated with an increased risk of gastroenteritis and intussusception among vaccinated infants This proposal seeks to develop a dissolving microneedle patch that overcomes the current drawbacks of rotavirus vaccination by incorporating an inactivated rotavirus vaccine IRV within microneedles for expected greater efficacy and immunogenicity based on preliminary data In this study we will screen IRV formulations and make microneedle patches that contain a full IRV human dose and that are stable at C for up to months We will also develop a draft manufacturing process for IRV microneedle patches that can be scaled up to meet the demands of vaccination campaigns Additionally we will perform a feasibility study of the manufacturing process that we will develop as part of this study and manufacture IRV microneedle patches that can subsequently be used in an animal model to assess the safety and immunogenicity of the IRV microneedle patch