Delivery of a candidate AgTRIOVx malaria vaccine by thermostable microneedle patches

ABSTRACT Malaria remains one of the deadliest infectious diseases. Although much progress has been made in the fight against malaria, a highly effective and durable vaccine is not available. New vaccine candidates and improved delivery strategies are urgently needed. We recently demonstrated that a Anopheles gambiae mosquito saliva protein, called AgTRIO, is a viable mRNA-LNP vaccine in mice, either as a single agent or in synergistic combination with the target of the currently marketed RTS,S/AS01 vaccine (Mosquirix). This project addresses the real-world problem of delivery of an antimalaria mRNA vaccine in endemic, resource-poor countries where cold- chain storage hugely limits deployment of mRNA vaccines. Our product solution employs novel dissolvable microneedle patches (MNPs) to administer our AgTRIO mRNA-LNP formulation. These microneedle patches can be self-applied, are less painful than intramuscular injection, produce no sharps waste, have a long-term shelf life for up to six months at room temperature, and can be produced at scale with robust methods. The single specific aim of this project is to produce a novel AgTRIOVx MNP that protects against malaria in a mouse model in preparation for pre-clinical and human clinical studies at a future phase.