UNIVERSAL STABILIZATION TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase II: ODCDC

Description

Problems exist with current influenza vaccines because of the need for refrigeration virus shedding professionals required for injection or liquid nasal administration and slow egg based production methods which are ineffective for pandemic situations This Phase II project aims to Optimize drying thermostabilization of two live attenuated influenza vaccines LAIV via UST patented Preservation by Vaporization technology The currently utilized BioDiem H N LAIV will be tested against new M SR vaccine produced by FluGen in a cell based system modified to eliminate M expression less likely to replicate and shed Once dried vaccine powders will be micronized and filled into nasal delivery devices Ferrets will be vaccinated via nasal powders Safety and immunogenicity will be assessed then homologous and heterologous influenza challenge will be performed to assess nasal wash virus titer mucosal antibody responses infection rate virus load and duration of shedding Expected outcome is appropriate response to challenge with both vaccines PBV thermostabilization micronization will decrease need for refrigeration allow nasal powder delivery which improves dose variability and eliminates need for professional administration The new M SR vaccine could allow more effective immunization without shedding and possibility of production more suited to needs of government during pandemic situations