AntiDoSE Microneedle Patch - An Antimicrobial, Dissolvable, and Stabilizing Excipient for Intradermal Delivery of Human Rabies Vaccine

ABSTRACT: Approximately 60,000 human deaths occur each year from rabies. Although rabies vaccines have been developed for pre- and post-exposure prophylaxis (PEP), remote communities are disproportionally susceptible to the life-threatening infection. In these communities, access to the requisite healthcare facilities is limited, and there are high costs and complex regimens associated with the treatment. Further, current vaccines require maintenance of cold chain and bulky packaging. Vaccine delivery administered intradermally using a dissolvable microneedle approach could result in key benefits such as reduced packaging and administrative needs, along with dose sparing cost savings. Challenges remain within the development of disposable microneedles for vaccine delivery, including maintenance of antigen stability without the need for cold chain and device sterilization. Luna proposes to address these limitations through development of the AntiDoSE microneedle patch. The technology builds upon existing work at Luna, and the stabilizing matrix is expected to reduce cold chain requirements while exhibiting antimicrobial behavior and controlled antigen release during dissolution. The proposed Phase I program includes objectives aimed at demonstrating the feasibility of the novel excipient for microneedle delivery of the human rabies vaccine.