B群脑膜炎球菌外膜蛋白偶联A+C群脑膜炎球菌结合疫苗的免疫原性研究

Study on Immunogenicity of Group A and Group C Meningococcal Conjugate Vaccine with Coupling Group B Meningococcal Outer Membrane Protein

目的了解B群脑膜炎球菌外膜蛋白(Group B Meningococcal Outer Membrane Protein,MenB-OMP)偶联A+C群脑膜炎球菌结合疫苗(Meningococcus Group A and Group C Conjugate Vaccine,MCVA+C)的免疫原性。方法按2:1比例随机双盲对照试验设计原则,观察3～5月龄、6～23月龄、2～6岁、7～24岁四个年龄组,检测免疫前、后A、B、C群血清杀菌抗体(Serum Bactericidal Antibody,SBA)。结果观察疫苗对不同年龄组免疫前、后A、B、C群SBA同时≥4倍增长率为97.65%～100%,SBA同时≥1:128的占88.89%～96.47%,几何平均滴度为1:194～1:420,与对照组相比差异有统计学意义。结论MenB-OMP偶联MCVA+C有良好的免疫原性。

Objective To evaluate the Immunogenicity of Group A and Group C Meningococcal conjugate Vaccine with coupling Group B Meningococcal Outer Membrane Protein （Men B-OMP）. Methods 458 healthy children aged 3-5 months, 6-23 months, 2-6 years and 7-24 years were given the Groups A and C conjugate Vaccine with MenB-OMP or other vaccine as control group to measure the pre-and post-vaccination Men A and C and B by Serum Bactericidal Assay （SBA） in the double-blind randomized controlled trial. Results 97.65%-100% were 4 times or greater increase in SBA titer for the healthy children given the Groups A and C conjugate Vaccine with MenB-OMP, The geometric mean titer of SBA were 1：194-1：420, which significantly higher than controls. Conclusion The Group A and C conjugate Vaccine with MenB-OMP was safe and well immunogenic.