Delivery of a candidate AgTRIOVx malaria vaccine by thermostable microneedle patches

L2 Diagnostics, Llc, New Haven CT

Investigators

Abstract

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.