Vacuum Foam Drying Method Improved the Thermal Stability and Long-Term Shelf Life of a Live Attenuated Newcastle Disease Virus Vaccine

文献类型： 外文期刊

第一作者： Lyu, Fang

作者： Lyu, Fang;Zhao, Yan-hong;Lu, Yu;Zuo, Xiao-xin;Deng, Bi-hua;Zeng, Min-qian;Wang, Jun-ning;Hou, Jibo;Lyu, Fang;Olaniran, Ademola;Khoza, Thandeka;Lyu, Fang;Zeng, Min-qian;Zhao, Yan-hong;Lu, Yu;Zuo, Xiao-xin;Deng, Bi-hua;Lu, Yu;Hou, Jibo

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关键词： attenuated live vaccines; newcastle disease virus; thermal stability; transition temperature; vacuum foam drying

期刊名称：AAPS PHARMSCITECH （ 影响因子：4.026； 五年影响因子：3.951 ）

ISSN： 1530-9932

年卷期： 2022 年 23 卷 8 期

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收录情况： SCI

摘要： Vaccines used for managing Newcastle disease virus (NDV) rely heavily on cold chain, and this results in major constraints in their successful application, shipping, and storage. This study was undertaken to improve the thermotolerance properties of live attenuated NDV vaccines using vacuum foam drying (VFD) technology. The live attenuated NDV vaccine formulated in 15% trehalose, 2.5% gelatin, 0.05% pluronic, and 25 mmol/L potassium phosphate buffer (T5) and dried using VFD showed improved heat tolerance in comparison to the vaccine formulated in T5 as well, but dried using freeze-drying (FD) method. The T5-formulated VFD vaccine was stored at 37 degrees C for 120 days, 45 degrees C for 7 days, and 60 degrees C for 3 days; the virus titer loss decreased by no more than 1.0 Log(10). In contrast, the FD vaccine prepared in T5 could only be stored at 37 degrees C for 7-10 days. Furthermore, the T5-formulated NDV-VFD vaccine remained infectious when heated at 100 degrees C for 30 min. Shelf-life studies confirmed the improved thermal tolerance of the T5-formulated NDV-VFD vaccine since it could be stably stored at 2-8 degrees C for 42 months and 25 degrees C for 15 months. Moreover, immunization of 1-month-old specific pathogen-free (SPF) chickens with the T5-formulated NDV-VFD vaccine stored at 25 and 37 degrees C could produce hemagglutination inhibition (HI) antibody levels comparable to those of commercial NDV-FD vaccines, which require strict adherence to the cold chain. In conclusion, not only did the VFD technology improve the thermostability and long-term shelf life of the vaccine, it also maintained its immunogenicity.

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