冻干A群脑膜炎球菌多糖结合疫苗的稳定性及氢氧化铝佐剂复溶疫苗的免疫效果

目的观察冻干A群脑膜炎球菌多糖-破伤风类毒素结合疫苗的稳定性,并比较A(lOH)3佐剂和磷酸盐缓冲液(PBS)复溶疫苗的免疫效果。方法将冻干疫苗于2～8℃放置36个月,每隔6个月取样,测定游离多糖含量、分子大小等,观察疫苗的稳定性。分别用A(lOH)3和PBS两种稀释液复溶疫苗后,计算吸附率并免疫小鼠,采用ELISA法测定小鼠血清中抗多糖IgG抗体滴度。结果疫苗于2～8℃放置30个月,各项质量指标均合格。A(lOH)3稀释液复溶疫苗的吸附率为100%。以两种稀释液复溶的疫苗均可诱导小鼠产生高滴度的抗多糖IgG抗体及免疫记忆反应,且A(lOH)3稀释液明显优于PBS稀释液。结论冻干A群脑膜炎球菌结合疫苗具有良好的稳定性,A(lOH)3佐剂可作为其稀释液。

Stability of Freeze-dried Group A Meningococcal Polysaccharide Conjugate Vaccine and Immune Effect of The Vaccine after Reconstitution with Aluminum Hydroxide Adjuvant

Objective To observe the stability of freeze-dried group A meningococcal polysaccharide conjugate vaccine and compare the immune effects of the vaccine after reconstitution with aluminum hydroxide adjuvant and PBS.Methods The freezedried vaccine was stored at 2 ～ 8℃ for 36 months,from which samples were taken every 6 months and determined for polysaccharide content and molecular size to evaluate the stability.The vaccine was reconstituted with aluminum hydroxide adjuvant and PBS respectively to determine the adsorption rates,with which mice were immunized and determined for serum IgG titers against polysaccharide by ELISA.Results After storage at 2 ～ 8℃ for 30 months,all the quality indexes of the freeze-dried vaccine met the relevant requirements.The adsorption rate of vaccine after reconstitution with aluminum hydroxide adjuvant was 100%.Both the vaccine reconstituted with aluminum hydroxide adjuvant and PBS induced high IgG titers against polysaccharide as well as immunological memory in mice,however,the IgG titer induced by the vaccine reconstituted with aluminum hydroxide adjuvant was higher than that with PBS.Conclusions Freeze-dried group A meningococcal polysaccharide conjugate vaccine showed high stability,and aluminum hydroxide adjuvant might be used for the reconstitution of the vaccine.