某新上市国产冻干A+C群脑膜炎球菌多糖结合疫苗免疫原性及安全性观察

Study on the safety and immunogenicity of a new home-made vaccine of freeze-dried group A/C meningococcal polysaccharide conjugate

目的评价某新上市国产冻干A＋C群脑膜炎球菌多糖结合疫苗接种婴幼儿的安全性和免疫原性。方法采用随机、盲法、对照的方法,选择900名6~23月龄健康儿童,其中6~11月龄300人,12~23月龄600人,每个年龄组按1∶1比例随机分到试验组和对照组。实验组接种某新上市疫苗,对照组接种罗益（无锡）生物制药有限公司生产的同类疫苗。每人接种2剂疫苗,间隔1个月,评价试验组和对照组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）。结果免疫后两个年龄段A、C群抗体阳转（4倍增长）率均〉95%,试验组与对照组的阳转率差异无统计学意义。12~23月龄接种1剂、2剂疫苗后抗体阳转率差异无统计学意义;6~11月龄段,试验组A群抗体水平高于对照组;两个年龄段试验组的C群抗体水平均低于对照组,但均处于较高水平（〉1∶128）。实验组与对照组全身及局部不良反应率差异无统计学意义,未观察到与试验疫苗相关的严重不良事件。结论某新上市国产冻干A＋C群脑膜炎球菌多糖结合疫苗在6~23月龄的儿童中具有良好安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of a new home-made vaccine of freeze-dried group A/C meningococcal polysaccharide conjugate （MCV-A/C） in infants. Methods The double-blind, randomized, parallel controlled clinical trial was conducted to evaluate the adverse reaction, the positive conversion rate and GMT of antibodies. The participants included 300 of 6-11 months and 600 of 12-23 months old children, who were randomly allocated to the trial group and control group by age at 1：1 ratio. Each participant was injected with 2 doses of the new brand （in the trial group） or old brand （in the control group） of the vaccine at an interval of 1 month. Results The positive conversion rates of antibodies to A, C antigens were over 95%both in the trial and control group, and there was no significant difference between two groups. In children of 12-23 months the positive conversion rates of antibodies after one injection had no significant difference to that of after the 2 injections. In children of 6-11 months the antibody levels to A were higher in the trial group than in the control group, while those to C at age of 6-23 months were lower in trial group than in the control group, but the titers were over 1：128. There was no serious adverse events reported in the trial vaccine and the systemic or local side effects were similar between the trial and control group. Conclusion The new home made vaccine of freeze-dried group A/C meningococcal polysaccharide conjugate has high safety and immunogenicity in the children at age of 6 -23 months.