VACCINE DELIVERY SYSTEM FOR LIVE ROTAVIRUS VACCINES

THE LONG-TERM OBJECTIVE OF THIS STUDY IS THE DEVELOPMENT OF AN EFFECTIVE DELIVERY SYSTEM FOR A LIVE HUMAN ROTAVIRUS VACCINE. TO AVOID THE INACTIVATION OF VIRUS BY GASTRIC ACID, DIFFERENT BUFFERS ARE BEING GIVEN BEFORE VACCINATION IN CURRENT VACCINE TRIALS. THIS PROJECT FOCUSES ON THE IMPROVEMENT OF THIS TIME- AND COST-CONSUMING PRESENT VACCINEADMINISTRATION PROCEDURE. TO EVALUATE THE EFFICACY OF DELIVERING A LIVE ROTAVIRUS VACCINE TO THE INTESTINAL TRACT, IT IS PLANNED TO ENCAPSULATE LIVE ROTAVIRUS IN A BIODEGRADABLE MICROCAPSULE. PRIOR TO MICROENCAPSULATION, THE STABILITY OFROTAVIRUS INFECTIVITY TO DIFFERENT ORGANIC SOLVENTS WILL BE STUDIED. FOLLOWING MICROENCAPSULATION, ROTAVIRUS MICROSPHERES WILL BE CHARACTERIZED WITH RESPECT TO THEIR SIZE DISTRIBUTION, MORPHOLOGY, AND VIRUS CONTENT. THE IN VITRO RELEASE RATE OF THE VIRUS FROM THE MICROCAPSULE WILL ALSO BE DETERMINED BY PLAQUE ASSAY. MICROENCAPSULATED ROTAVIRUS WILL THEN BE TREATED WITH LOW PH AS WELL AS WITH VARIOUS PROTEASES, AND THE VIRUS INFECTIVITY WILL BE EXAMINED IN ORDER TO TEST THE STABILITY OF INFECTIVITY IN THE GASTRIC ENVIRONMENT. ONCE SATISFACTORY RESULTS ARE OBTAINED, AN IN VIVO IMMUNIZATION STUDY USING PIGLETS WILL BE CARRIED OUT IN PHASE II.