伤寒Vi多糖、白喉、破伤风联合疫苗初探

Preliminary observation of typhoid Vi polysaccharide, diphtheria and tetanus combined vaccine

目的 制备成人及青少年用吸附伤寒 Vi多糖、白喉、破伤风联合疫苗 ,观察伤寒 Vi多糖含量、白喉及破伤风效价。方法 按设计的配方 ,将白喉、破伤风类毒素加入佐剂中吸附后 ,再加入伤寒 Vi多糖 ,要求配制的吸附伤寒 Vi多糖、白喉、破伤风联合疫苗每人用剂量 0 .5 ml伤寒 Vi多糖含量≥ 30 μg,白喉类毒素效价≥ 2 IU,破伤风类毒素效价≥ 4 0 IU。结果 三组配方试验样品每人用剂量 0 .5 ml伤寒 Vi多糖含量均低于30 μg,白喉类毒素效价 3.12 7IU～ 5 .911IU,破伤风类毒素效价 7.784 IU～ 2 3.976 IU。除白喉类毒素效价达到要求外 ,伤寒 Vi多糖含量及破伤风类毒素效价未达到要求。结论 初探试验表明 ,试验的联合疫苗存在抗原干扰 ,伤寒 Vi多糖含量及破伤风类毒素效价下降。

Objective To investigate the Vi polysaccharide content, the potency of diphtheria and tetanus toxoids in the typhoid Vi polysaccharide, diphtheria and tetanus combined vaccine (adsorbed)for adults and adolescents. Methods According to the formulations, the typhoid Vi polysaccharide is added into the preparation of diphtheria and tetanus toxoids adsorbed onto aluminum hydroxide. Each single human dose (0.5ml) is required to contain not less than 30μg of polysaccharide, 2IU of diphtheria toxoid and 40IU of tetanus toxoid. Results The results of three samples show that the Vi polysaccharide content is less than 30μg;the potency of diphtheria toxoid is between 3 127 and 5.911IU;the potency of tetanus toxoid is between 7.784 and 23.976IU. All the results except the potency of diphtheria toxoid do not meet the requirements. Conclusions These results suggest that there are interferences among the antigens in the testing combined vaccine.