冻干A+C群脑膜炎球菌多糖疫苗安全性和免疫原性观察

为了评价冻干A+C群脑膜炎球菌多糖疫苗(MPV)的安全性和免疫原性,按随机、盲法的原则,评价疫苗免疫后不良反应发生率、抗体阳转率及抗体几何平均滴度(GMT)。将606名健康观察者分为2～5岁、6～12岁、13～17岁、18～60岁四个年龄组,结果显示,该疫苗全身反应发生率2.64%,局部反应发生率1.32%,四个年龄组疫苗免疫后杀菌抗体阳性率分别为100%、100%、99.3%和100%,免疫后A群杀菌抗体GMT分别为1:250.47、1:190.61、1:144.22和1:205.79,免疫后C群杀菌抗体GMT分别为1:273.33、1:551.18、1:788.26和1:809.81,冻干A+C群多糖疫苗在≥2岁人群中具有良好的安全性和免疫原性,建议推广使用A+C群MPV。

Observation on the safety and immunogenicity of group A+C meningococcal polysaccharide vaccine

To evaluate the safety and immunogenicity of group A+C meningococcal polysaccharide vaccine.The blind randomized,controlled clinical trial was carried out to evaluate the side effect rate,the positive seroconversion rate and GMT.606 healthy volunteers,aged 2 to 50 years old,were divided into four age groups:2-5 years group,6-12 years age group,13-17 years age group and 18-60 years age group.The systemic side effect rates of the experimental group is 2.64%,and the local side effect rate is 1.32%.Seropositive conversion rate of experiment group is 100%,100%,99.3% and 100% in four groups,respectively.Seropositive conversion GMT of experiment groups A is 1:250.47,1:190.61,1:144.22 and 1:205.79,respectively,and seropositive conversion GMT of experiment groups C is 1:273.33,1:551.18,1:788.26 and 1:809.81,respectively.The group A+C meningococcal polysaccharide vaccine is safe and immunogenic for all volunteers between 2 to 60 years old.The vaccine should be commended to vaccine population that is sensitive to group A+C meningococcal.