Thermostable Sublingual Measles Vaccine Dry Wafers

"Measles is a highly contagious, human disease that is spread by the respiratory route, and, in the developing world, remains a leading cause of death due to vaccine-preventable infectious diseases in children younger than 5 years. The most recent estimates are that there were 139,300 deaths worldwide in 2010 due to measles. Research priorities to help achieve the goals of controlling, and eventually eradicating, measles worldwide should include the development of thermostable alternative delivery methods to improve vaccine safety, effectiveness, and coverage. In this Phase I SBIR project, we aim to develop dry wafer formulations for sublingual administration that are thermally stable (Aim 1) and immunogenic (Aim 2). We will use Aktiv-Dryʼs patented CO2-Assisted Nebulization with a Bubble Dryer® (CAN-BD) technology to prepare dry powders of measles vaccine formulations containing novel excipients to enhance stability. These powders will then be processed into wafers. We anticipate the outcome of the proposed research will be the development of a dry wafer formulation that exhibits less than one log loss in measles vaccine virus titer after 6 months of storage at 37 °C. Furthermore, the sublingual vaccine wafers will clearly induce an immune response in cotton rats, an accepted model for measles research.