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首页> 外文期刊>Vaccine >Room temperature stabilization of oral, live attenuated Salmonella enterica serovar Typhi-vectored vaccines.
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Room temperature stabilization of oral, live attenuated Salmonella enterica serovar Typhi-vectored vaccines.

机译：口服减毒肠沙门氏菌血清型伤寒载体疫苗的室温稳定性。

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Foam drying, a modified freeze drying process, was utilized to produce a heat-stable, live attenuated Salmonella Typhi 'Ty21a' bacterial vaccine. Ty21a vaccine was formulated with pharmaceutically approved stabilizers, including sugars, plasticizers, amino acids, and proteins. Growth media and harvesting conditions of the bacteria were also studied to enhance resistance to desiccation stress encountered during processing as well as subsequent storage at elevated temperatures. The optimized Ty21a vaccine, formulated with trehalose, methionine, and gelatin, demonstrated stability for approximately 12 weeks at 37 degrees C (i.e., time required for the vaccine to decrease in potency by 1 log10 CFU) and no loss in titer at 4 and 25 degrees C following storage for the same duration. Furthermore, the foam dried Ty21a elicited a similar immunogenic response in mice as well as protection in challenge studies compared to VivotifTM, the commercial Ty21a vaccine. The enhanced heat stability of the Ty21a oral vaccine, or Ty21a derivatives expressing foreign antigens (e.g. anthrax), could mitigate risks of vaccine potency loss during long-term storage, shipping, delivery to geographical areas with warmer climates or during emergency distribution following a bioterrorist attack. Because the foam drying process is conducted using conventional freeze dryers and can be readily implemented at any freeze drying manufacturing facility, this technology appears ready and appropriate for large scale processing of foam dried vaccines.Digital Object Identifier http://dx.doi.org/10.1016/j.vaccine.2011.01.093
机译：泡沫干燥是一种改良的冷冻干燥工艺，被用于生产热稳定的减毒活型沙门氏菌伤寒沙门氏菌“ Ty21a”细菌疫苗。 Ty21a疫苗是用药学上认可的稳定剂配制的，包括糖，增塑剂，氨基酸和蛋白质。还研究了细菌的生长培养基和收获条件，以增强对加工以及随后在高温下储存过程中遇到的干燥压力的抵抗力。经优化的由海藻糖，蛋氨酸和明胶配制的Ty21a疫苗在37摄氏度（即疫苗效力降低1 log 10 CFU所需的时间）下表现出约12周的稳定性，并且储存相同时间后，在4和25摄氏度下滴度没有损失。此外，泡沫干燥的Ty21a与商用Ty21a疫苗Vivotif TM 相比，在小鼠中引起了相似的免疫原性应答，并且在攻击研究中产生了保护作用。 Ty21a口服疫苗或表达外源抗原（例如炭疽）的Ty21a衍生物的热稳定性增强，可以减轻长期储存，运输，运送到气候变暖的地理区域或发生生物恐怖分子后的紧急分发期间疫苗效价损失的风险。攻击。由于泡沫干燥过程是使用传统的冷冻干燥机进行的，并且可以在任何冷冻干燥生产设施中轻松实施，因此该技术似乎已经准备就绪，适合大规模处理泡沫干燥疫苗.Digital Object Identifier http://dx.doi.org /10.1016/j.vaccine.2011.01.093

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