Development of a stabilizer for lyophilization of an attenuated duck viral hepatitis vaccine

Abstract

The live attenuated vaccine against duck viral hepatitis currently available in Korea requires special freezers for storage and transportation with extra costs involved. The development of a lyophilization stabilizer for live attenuated duck viral hepatitis virus (DHV) vaccines, therefore, has been highly recommended for the wider application of the vaccines. Four conventional vaccine stabilizer formulations containing a disaccharide, such as lactose, trehalose, or sucrose, and new formulations containing sorbitol were tested for their efficacy in stabilizing a new attenuated DHV type 3 vaccine candidate under different storage temperatures, 4 and 37 degrees C. The vaccine virus and each stabilizer formulation were combined and submitted to lyophilization and the viability of the virus was measured in 7-d-old specific-pathogen-free chicken embryos by determining the 50% egg lethal dose. Stabilizer formulations containing 2, 4, or 8% sorbitol preserved the viability of the vaccine virus much better than the other stabilizer formulations and 2% sorbitol was the optimal concentration in a standard stabilizing buffer, phosphate glutamate gelatin (0.0038 M KH2PO4, 0.0071 M K2HPO4, 0.0049 M monosodium L-glutamate, and 0.5% gelatin). The results demonstrate that the stabilizer formulation containing 2% sorbitol and 0.5% gelatin can be used for convenient storage and transportation of live DHV vaccines.