脑膜炎球菌多糖疫苗安全性及免疫原性评价

Evaluation on safety and immunogenicity of tetravalent A/C/W_(135)/Y meningococcal polysaccharide vaccine

目的评价A、C、W135和Y群脑膜炎球菌多糖疫苗在2~30岁健康人群中接种的安全性与免疫原性。方法采用随机、双盲和平行对照的设计方法 ,对A、C、W135和Y群脑膜炎球菌多糖疫苗接种人群不良反应发生率、抗体阳转率、平均几何滴度（GMT）进行比较。结果免疫后对照组与试验组总体不良反应发生率分别为11.21%和13.79%,其中全身反应发生率分别为6.06%和5.30%,局部反应发生率分别为6.06%和9.85%;免疫后28d,试验组A、C、W135和Y群抗体阳转率均〉94.00%,A和C群抗体阳转率与对照组比较差异均无统计学意义（均P〉0.05）,W135和Y群抗体阳转率与对照组比较差异有统计学意义,试验组高于对照组;免疫后抗体GMT分别为A群=394.81、C群=237.32、W135群=326.00、Y群=226.45,均达到保护性水平。结论 A、C、W135和Y群脑膜炎球菌多糖疫苗在2~30岁健康人群中接种有较好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of the tetravalent A/C/W135/Y meningococcal polysaccharide vaccine for subjects at age of 2-30 years.Methods A double-blind,randomized,parallel controlled clinical trial was carried out to evaluate side effect rate,positive seroconversion rate and geomatric mean titer（GMT） of the vaccine.Results The side effect rates of the experimental group and the control group were 13.79% and 11.21%;the systemic side effect rates were 5.30% and 6.06% and the local site effect rates were 9.85% and 6.06%,respectively.Seropositive conversion rates of A/C/W135/Y sterilizing antibody of the experiment group were more than 94.0% with the GMT values of 1：394.81,1：237.32,1：326.00,and 1：226.45,respectively.Seropositive conversion rates and values of GMT of W135 and Y sterilizing antibody between the experimental group and the control group were significantly different.Conclusion The group A/C/W135/Y meningococcal conjugate vaccine has good safety and immunogenicity for health persons between 2 to 30 years old.