Heat stable liquid rotavirus vaccine

Abstract

The invention is directed to an oral vaccine composed of a micronized freeze-dried rotavirus particle emulsion with buffering excipients in a non-aqueous liquid. This IVT-06 formulation has imparted heat stability by protecting the virus at temperatures of 30°C and 40°C for at least twelve months. Extrapolations from the 12-month stability data indicate a shelf life of more than two years at 30°C, and six months at 50°C. In addition, for ease of administration, the formulated dose has a volume of 0.5 mL.