Cryz S J, Pasteris O, Varallyay S J, Fürer E
Swiss Serum and Vaccine Institute, Berne, Switzerland.
Dev Biol Stand. 1996;87:277-81.
Live oral attenuated vaccines against typhoid fever (Salmonella typhi Ty21a) and cholera (Vibrio cholerae CVD 103-HgR) have been licensed for human use. Vaccine potency is dependent upon each dose containing a minimum number of viable organisms and galenic parameters. To ensure long-term stability, such vaccines must be stored at 5 degrees C +/- 3 degrees C. However, exposure to ambient temperatures (25 degrees C) for short periods of time (< 7 days) does not compromise vaccine potency. Brief exposures (< or = 24 hours) to temperatures as high as 37 degrees C will also not render the vaccine unsuitable for use. The Ty21a vaccine is available either as enteric-coated capsules or as a "liquid formulation", while CVD 103-HgR is presented only in the latter form. Each galenic formulation presents unique challenges with regard to the production of stable vaccines. Residual moisture, excipients, and processing temperatures during manufacturing were all found to markedly affect vaccine stability.
伤寒（伤寒杆菌Ty21a）和霍乱（霍乱弧菌CVD 103-HgR）的口服减毒活疫苗已获许可用于人类。疫苗效力取决于每剂所含的最低活菌数和药剂参数。为确保长期稳定性，此类疫苗必须储存在5摄氏度±3摄氏度的环境中。然而，短时间（<7天）暴露于环境温度（25摄氏度）不会损害疫苗效力。短暂暴露（≤24小时）于高达37摄氏度的温度也不会使疫苗不适于使用。Ty21a疫苗有肠溶胶囊或“液体制剂”两种形式，而CVD 103-HgR仅以后一种形式提供。每种药剂配方在生产稳定疫苗方面都面临独特挑战。制造过程中的残留水分、辅料和加工温度均被发现会显著影响疫苗稳定性。
