Microneedle patch for the stabilization and dose-sparing delivery of rabies vaccine

PROJECT ABSTRACT Approximately 60,000 human deaths occur each year from rabies. Although rabies vaccines have been developed for pre- and post-exposure prophylaxis (PEP), access to vaccination has limited prevention and treatment of the life-threating infection. Developing countries and remote communities are disproportionally susceptible, compounded by high costs and complex regimens (multiple boosters) associated with treatment. Further, rabies and many other vaccines require maintenance of cold chain up to the point of administration. Vaccine delivery intradermally using a dissolvable microneedle approach could result in key benefits such a more rapid immune response at a reduced administered dose, and improved antigen stability would be significant. Luna Labs therefore proposes to advance development of a resorbable microneedle patch for intradermal administration of human rabies vaccine. The proposed technology builds upon existing work at Luna Labs, and the novel excipient will support the room-temperature stabilization of the vaccine prior to controlled resorption and antigen release. Antigen loading will be optimized, and the approach will enable consistent, reliable immunization with minimal training. The Phase I effort will demonstrate feasibility for microneedle delivery of the stabilized human rabies vaccine in an in vivo study of antigenicity, and future work will expand study of vaccine stability and preclinical safety and efficacy.