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

机译:用于减毒鸭病毒性肝炎疫苗冻干的稳定剂的开发

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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.
机译:韩国目前可获得的针对鸭病毒性肝炎的减毒活疫苗需要特殊的冰柜进行储存和运输,但需要额外的费用。因此,强烈建议为减毒活鸭病毒性肝炎病毒(DHV)疫苗开发一种冻干稳定剂,以更广泛地应用该疫苗。测试了四种包含二糖(例如乳糖,海藻糖或蔗糖)的常规疫苗稳定剂制剂以及包含山梨糖醇的新制剂在不同的储存温度(4和37摄氏度)下稳定新的3型DHV减毒候选疫苗的功效。组合疫苗病毒和每种稳定剂制剂并冻干,并通过确定50%的卵致死剂量,在7天大的无特定病原体的鸡胚中测量病毒的生存力。含有2、4,或8%山梨糖醇的稳定剂制剂比其他稳定剂制剂更好地保留了疫苗病毒的生存力,在标准稳定缓冲液磷酸谷氨酸明胶(0.0038 M KH2PO4、0.0071 M K2HPO4 ,0.0049 M 1-谷氨酸钠和0.5%明胶)。结果表明,包含2%山梨糖醇和0.5%明胶的稳定剂配方可用于方便地存储和运输DHV活疫苗。

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