A群C群脑膜炎球菌多糖-白喉毒素无毒突变蛋白CRM 197结合疫苗的稳定性

Stability of groups A and C meningococcal polysaccharide-CRM197 conjugate vaccine

目的分析以白喉毒素无毒突变蛋白CRM197为载体的A群C群脑膜炎球菌结合疫苗原液及成品在不同储存条件下主要质量指标的变化,为该疫苗保存条件及有效期的制定提供依据。方法将A群、C群结合物原液分别在2~8℃放置3、6、8个月,20~25℃放置4、6周后,进行主要质量指标的检测;结合疫苗成品于2~8℃放置3、6、12、18、24个月,20~25℃放置3、6个月,35~37℃放置3、4周后,进行主要质量指标的检测。结果C群结合物原液2~8℃保存8个月,20~25℃放置6周后,A群结合物原液2~8℃放置8个月,20~25℃放置3周后,各项质量指标均符合要求;成品于2~8℃放置24个月,20~25℃放置6个月,35~37℃放置4周后,各项质量指标均符合要求。结论以CRM197为载体的A群C群脑膜炎球菌结合疫苗原液及成品均具有良好的质量稳定性。

Objective To analyze the changes of main quality indexes of bulk and final product of groups A and C meningococcal polysaccharide conjugate vaccine using CRM 197,an avirulent mutant of diphtheria toxin,as carrier protein under various conditions for storage,and provide a basis for determination of condition for storage and validity period of the vaccine.Methods The bulks of groups A and C conjugate were stored separately at 2-8 ℃ for 3,6 and 8 months,and at 20-25 ℃ for 4 and 6 weeks,while the final product was stored at 2-8 ℃ for 3,6,12,18 and 24 months,at 20-25 ℃ for 3 and 6 months,and at 35-37 ℃ for 3 and 4 weeks,of which the main quality indexes were determined.Results All the quality indexes of bulk of group C met the relevant requirements after storage at 2-8 ℃ for 8 months and at 20-25 ℃ for 6 weeks,while those of group A at 2-8 ℃ for 8 months and at 20-25 ℃ for 3 weeks.However,all the quality indexes of final product met the relevant requirements after storage at 2-8 ℃ for 24 months,at 20-25 ℃ for 6 months and at 35-37 ℃ for 4 weeks.Conclusion Both the bulk and final product of groups A and C meningococcal polysaccharide conjugate vaccine using CRM 197 as carrier showed high stability.