双价痢疾结合疫苗的安全性及免疫原性

Safety and Immunogenicity of Bivalent Shigella Conjugate Vaccine

目的 研究双价痢疾结合疫苗的安全性及免疫原性。方法 将福氏 2aO -SP- rEPA结合疫苗和宋内氏O -SP- rEPA结合疫苗混合制备成双价痢疾结合疫苗 ,对该双价结合疫苗的安全性及免疫原性与痢疾单价结合疫苗进行比较。结果 双价痢疾结合疫苗安全可靠 ,在 4℃放置 0月、6月、12月与单价结合疫苗相比 ,小鼠血清抗体应答水平差异无显著性意义。结论 混合后没有改变两个单价结合疫苗的特性 ,且稳定性良好 ,可预防福氏 2a、宋内氏痢疾菌所引起的感染。

Objective To study the safety and immunogenicity of bivalent Shigella conjugate vaccine by mixing the bulks of Shigella flexneri 2a and Shigella sonnei conjugate vaccines.Methods Compare the safety and immunogenicity of bivalent vaccine with those of 2 kinds of monovalent vaccines.Results The bivalent Shigella conjugate vaccine was safe.The serum antibody response levels of mice induced by the bivalent vaccine after storage at 4℃ for 0,6 and 12 months showed no significant difference from those induced by either of the monovalent vaccine.Conclusion The properties of monovalent Shigella flexneri 2a and Shigella sonnei conjugate vaccines showed no significant change after being mixed.The prepared bivalent vaccine was stable and could be used for the prevention of infection with Shigella flexneri 2a or Shigella sonnei.