宋内菌痢疾结合疫苗临床安全性和免疫原性观察

摘要

目的 观察宋内菌痢疾结合疫苗临床安全性和免疫原性.方法按随机、双盲原则,以宋内菌痢疾结合疫苗为试验组,磷酸缓冲盐水为安慰剂对照组,进行临床安全性及免疫原性观察,比较试验组和对照组免疫后临床反应率、抗体阳转率和几何平均滴度(GMT)水平.结果宋内菌痢疾结合疫苗接种后无严重全身反应和局部反应,与对照组比较,差异无统计学意义.试验组经2针全程免疫后2周和12周,抗体阳转率分别为87.46%和82.32%;GMT分别为1∶3250.12和1∶2432.76;抗宋内菌脂多糖(LPS)-IgG抗体滴度较免前平均增长倍数分别为10.7374和8.0353.全程免疫后试验组与对照组之间抗体阳转率、GMT、抗体滴度平均增长倍数比较,差异均有统计学意义.结论宋内菌痢疾结合疫苗具有较好的安全性和免疫原性.%Objective To evaluate clinical safety and immunogenicity of Shigella sonnei conjugate vaccine. Methods A randomized double-blind study was carried out to evaluate the adverse reaction rate as well as seroconversion rate and antibody GMT of Shigella sonnei conjugate vaccine, using phos-phate buffer saline as control. Results No severe local or systemic adverse reactions were observed af-ter immunization with Shigella sonnei conjugate vaccine. No significant difference was found in the local and systemic adverse reaction rates between trial group and control group. The seroeonversion rates of tri-al group 2 and 12 weeks after the two-close schedule were 87.46% and 82.32% ,respectively, and the an-times,respectively,as compared with those before immunization. The seroconversion rate as well as anti-body GMT and its increasing of trial group were significantly higher than those of control group. Con-clusion Shigella sonnei conjugate vaccine showed good clinical safety and immunogenicity.