UNIVERSAL STABILIZATION TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase II: WHO estimates that each day, 380 children die from measles and 300 children get birth defe

Description

WHO estimates that each day, 380 children die from measles and 300 children get birth defects from congenital rubella syndrome, while an unknown number die in utero from rubella, mostly in developing countries because of cost and poor access. In order to reach these populations, a vaccine for measles and rubella must be developed that is inexpensive, easy to administer and can be maintained without refrigeration. The long-term goal of this project is to produce and test a measles-rubella combination vaccine powder that can be administered nasally or dissolved in the mouth. The primary technological innovation that makes this possible is the patented “Preservation by Vaporization” technology developed by the PI. In preliminary experiments with measles and other vaccines, stable powders have been produced in high yield that can be stored at least 10 months at 37°C. The specific aims of this project are: 1) Develop a formulation for stable measles-rubella vaccine powder utilizing the PBV process 2) Micronize product to an inhalable particle size 3) Prepare two alternative delivery systems a) powder inhaler b) oral melting strips 4) Test immunogenicity in non-human primates after storage at 37°C for one year. The expected results are that the vaccine will be easy to administer, very inexpensive to produce, and can be stored at ambient temperatures