Ahuja S, Gupta R K, Sharma S B, Maheshwari S C, Bhandari S K, Saxena S N
Biological Standardization and Quality Control Division, Central Research Institute, Kasauli, India.
Vaccine. 1987 Sep;5(3):184-6. doi: 10.1016/0264-410x(87)90097-1.
The stability of cholera vaccine samples held at 4-8 and 20-25 degrees C for 2 1/2 years was studied with regard to the number of organisms, total nitrogen content and relative antigenicity. After this length of time, the percentage loss in the number of organisms averaged 10.7 at 4-8 degrees C and 22.7 at 20-25 degrees C. The maximum loss in number of organisms took place during the first six months and in the next two years there was very little loss in the number of organisms. The total nitrogen content after 2 1/2 years remained almost unaltered at these temperatures. All the ten samples had acceptable relative antigenicity for both the Inaba and Ogawa serotypes after exposure at 4-8 degrees C for 2 1/2 years, while at 20-25 degrees C only two samples for the Inaba serotype and one sample for the Ogawa serotype retained antigenicity within acceptable limits after the same time. The loss of antigenicity after 2 1/2 years at 20-25 degrees C in comparison with antigenicity at 4-8 degrees C ranged from 41.5 to 83.1% (mean 61.9%) for the Inaba serotype and from 47.3 to 80.3% (mean 65.1%) for the Ogawa serotype. From this study on the cholera vaccine manufactured at the Central Research Institute, Kasauli, it is concluded that the shelf life of cholera vaccine may be increased from 18 months to at least 24 months, when the vaccine is stored under refrigeration.
研究了霍乱疫苗样本在4 - 8摄氏度和20 - 25摄氏度下保存2年半后的稳定性,涉及生物体数量、总氮含量和相对抗原性。经过这段时间后,生物体数量的损失百分比在4 - 8摄氏度下平均为10.7%,在20 - 25摄氏度下为22.7%。生物体数量的最大损失发生在前六个月,在接下来的两年中生物体数量损失很少。在这些温度下,2年半后总氮含量几乎保持不变。所有十个样本在4 - 8摄氏度下暴露2年半后,对稻叶型和小川型血清型均具有可接受的相对抗原性,而在20 - 25摄氏度下,经过相同时间后,稻叶型血清型只有两个样本、小川型血清型只有一个样本的抗原性保持在可接受范围内。与4 - 8摄氏度下的抗原性相比,20 - 25摄氏度下2年半后稻叶型血清型的抗原性损失范围为41.5%至83.1%(平均61.9%),小川型血清型为47.3%至80.3%(平均65.1%)。从对卡萨利中央研究所生产的霍乱疫苗的这项研究得出结论,当疫苗冷藏保存时,霍乱疫苗的保质期可从18个月延长至至少24个月。