冻干A+C群脑膜炎球菌结合疫苗的安全性和免疫原性

Safety and Immunogenicity of Groups A + C Meningococcal Conjugate Vaccine

目的观察冻干A+C群脑膜炎球菌结合疫苗的安全性和免疫原性。方法遵循随机、对照、盲法的原则,选择6～9月龄和≥3岁人群,分别接种观察组(冻干A+C群脑膜炎球菌多糖结合疫苗)和对照组(6～9月龄:A群脑膜炎球菌多糖疫苗;≥3岁:对照A+C群脑膜炎球菌多糖疫苗)疫苗,观察接种反应、血清抗体含量及抗体阳转率。结果免疫后6～9月龄观察组和对照组全身反应总发生率分别为1.67%和4.58%,局部反应总发生率分别为0.83%和2.08%;≥3岁观察组和对照组全身反应总发生率分别为2.50%和3.33%,局部反应总发生率均为0.83%。6～9月龄观察组和对照组免后A群抗体含量分别为22.27和3.61μg/ml,抗体阳转率分别为99.01%和66.67%,两组差异有统计学意义(P<0.05);≥3岁观察组A、C群抗体含量分别为21.28和17.94μg/ml,抗体阳转率分别为99.04%和98.08%;≥3岁对照组A、C群抗体含量分别为34.43和22.66μg/ml,抗体阳转率均为98.04%,两组间抗体含量差异有统计学意义(P<0.05),但阳转率差异无统计学意义(P>0.05)。结论冻干A+C群脑膜炎球菌结合疫苗在6～9月龄组与3岁及以上组人群中接种具有良好的安全性和免疫原性。

Objective To observe the safety and immunogenicity of freeze-dried groups A ＋ C meningococcal conjugate vaccine. Methods A double-blind, randomized and parallel controlled clinical trial was carried out in the children at ages of 6 ～ 9 months and not less than 3 years. The children in trial groups were immunized with freeze-dried groups A ＋ C meningococcal conjugate vaccine. However, in control groups, the children at ages of 6 ～ 9 months were immunized with group A meningococcal polysaccharide vaccine, while those at ages of not less than 3 years with groups A ＋ C meningococcal polysaccharide vaccine. The adverse reaction, serum antibody content and antibody positive conversion rate after immunization were observed. Results The systemic adverse reaction rates in the children at ages of 6 ～ 9 months in trial and control groups were 1. 67% and 4. 58%, while those of local adverse reaction rates were 0. 83% and 2. 08%, respectively. However, the systemic adverse reaction rates in the children at ages of not less than 3 years in trial and control groups were 2. 50% and 3. 33% respectively, while those of local adverse reaction rates were both 0. 83%. The contents of antibody against group A meningococcus in sera of children at ages of 6 ～ 9 months in trial and control groups were 22. 27 and 3. 61 μg / ml, while the antibody positive conversion rates were 99. 01% and 66. 67%, respectively, which showed significant difference（P 0. 05）. The contents of antibodies against groups A and C menigococcus in sera of children at ages of not less than 3 years in trial group were 21. 28 and 17. 94 μg / ml, while the antibody positive conversion rates were 99. 04% and 98. 08%, respectively. However, in the sera of children at ages of not less than 3 years in control group, the contents of antibodies against groups A and C menigococcus were 34. 43 and 22. 66 μg / ml respectively, while the antibody positive conversion rates were both 98. 04%. The antibody contents of children at ages of not less than 3 years in trial and control groups showed significant difference（P 0. 05）, while the antibody positive conversion rates showed no significant difference（P 0. 05）. Conclusion Freeze-dried groups A ＋ C meningococcal conjugate vaccine showed high safety and immunogenicity in the children at ages of 6 ～ 9 months and not less than 3 years.