不含硫柳汞重组乙型肝炎疫苗(CHO细胞)的免疫原性及稳定性

目的观察不含硫柳汞重组乙型肝炎疫苗(CHO细胞)的免疫原性及其稳定性。方法配制12批不含硫柳汞的重组乙型肝炎疫苗(CHO细胞),观察其免疫原性及在4、22和37℃保存不同时间的稳定性。结果该疫苗各项检测指标均符合《中国药典》三部(2005版)要求,实验组与对照组的效价测定结果差异无显著意义。10μg/ml疫苗22℃放置6个月和4℃放置12个月效力均未下降;20μg/ml疫苗在37℃放置4周后,效力略有下降。结论为婴幼儿提供了一种更加安全有效的重组乙型肝炎疫苗。

Immunogenicity and Stability of Thiomersal-free Recombinant Hepatitis B Vaccine( CHO Cells)

Objective To observe the immunogenicity and stability of thiomersal-free recombinant hepatitis B vaccine(CHO cells).Methods Prepare 12 batches of thiomersal-free recombinant hepatitis B vaccine(CHO cells).Immunize BALB/c mice with the prepared vaccine,determine the anti-HBs and calculate the ED50,using reference vaccine as control.Store the vaccine at 4,22 and 37℃ and observe the stability.Results All the quality indexes of the prepared vaccine met the requirements in Chinese Pharmacopoeia(Volume Ⅲ,2005).The ED50 of the vaccine showed no significant difference with that of reference vaccine.After storage at 22℃ for 6 months or at 4℃ for 12 months,the potency of vaccine at a specification of 10 μg/ml showed no significant decrease;after storage at 37℃ for 4 weeks,the potency of vaccine at a specification of 20 μg/ml showed only a slight decrease.Conclusion A more safe and more effective recombinant hepatitis B vaccine for infants was developed.