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.

Grant Number: 5R41AI184218-02
NIH Institute/Center: NIH
Principal Investigator: KAREN ANTHONY