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Live vaccine preserved at room temperature: Preparation and characterization of a freeze-dried classical swine fever virus vaccine

文献类型： 外文期刊

作者： Zuo, Xiao-xin 1 ; Zhao, Yan-hong 1 ; Zhou, Ming-xu 1 ; Deng, Bi-hua 1 ; Hu, Lai-gen 1 ; Lv, Fang 1 ; Lu, Yu 1 ; Hou, Ji-b 1 ;

作者机构： 1.Jiangsu Acad Agr Sci, Natl Res Ctr Engn & Technol Vet Biol, Inst Vet Immunol & Engn, Nanjing 210014, Peoples R China

2.Minist Sci & Technol, Jiangsu Key Lab Food Qual & Safety, State Key Lab Cultivat Base, Nanjing 210014, Peoples R China

3.Yangzhou Univ, Jiangsu Co Innovat Ctr Prevent & Control Importan, Yangzhou 225009, Jiangsu, Peoples R China

4.Jiangsu Univ, Sch Pharm, Zhenjiang 212013, Jiangsu, Peoples R China

关键词： Live-attenuated classical swine fever virus vaccine; Stabilizers; Thermostability; Amorphous state; Glass transition temperature; Residual water content

期刊名称：VACCINE （ 影响因子：3.641； 五年影响因子：3.816 ）

ISSN： 0264-410X

年卷期： 2020 年 38 卷 52 期

页码：

收录情况： SCI

摘要： The heat-stable live-attenuated classical swine fever virus (CSFV) vaccine is an urgent need in many countries of Asia, Europe and Latin America. In this study, the thermostability of lyophilized live attenuated CSFV vaccine formulations were investigated using accelerated stability at 37 degrees C for 10 days. The freeze-dried heat-stable formulation ST16, containing excipient combinations of trehalose, glycine, thiourea and phosphate buffer shows the superior thermostability. Moreover, the lyophilized vaccine with formula ST16 kept loss of viral activity less than 0.5 log(10) during 24 months at storage temperatures of 2-8 degrees C. In thermal study, ST16 stabilized the vaccine within 1.0 log(10) loss after storage at up to 25 degrees C for 6 months and room temperature for 7 months. Even under the harshest storage conditions of 37 degrees C for 25 days and 45 degrees C for 2 weeks, the virus titer dropped less than 1.0 log(10) using ST16. Besides, it is notable that ST16 excluded gelatin and exogenous proteins, which might cause allergic reactions, thus avoiding immune side effects. The vaccine formulated ST16 proved to be safe and effective when immunized to piglets in vivo. The characteristics of dried vaccines were analyzed by X-ray powder diffraction, residual water measurements, differential scanning calorimetry and it was found that vaccine antigen were preserved in an amorphous matrix with high glass transition temperature above 60 degrees C and low residual water content below 2%, which made the vaccine more stable during storage. (c) 2020 Elsevier Ltd. All rights reserved.

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