摘要
目的 观察评价A群脑膜炎球菌多糖结合疫苗安全性和免疫原性。方法 在江苏省射阳县将236名3～4月龄健康婴儿随机分为2组，分别接种试验疫苗和对照疫苗，观察接种后的安全性及2针免疫后1个月、3针免疫后1个月的免疫原性。结果 A群脑膜炎球菌多糖结合疫苗无严重的全身反应。试验疫苗组2针免疫后1个月和3针免疫后1个月，抗体几何平均滴度（GMT）与免疫前相比均达到≥4倍增长，阳转率均为100％。抗体GMT分别上升68．45、1115．83倍，与对照组抗体GMT差异有非常显著的统计学意义（P〈0．001）。结论 A群脑膜炎球菌多糖结合疫苗是安全的，有良好的免疫原性。
Objective To evaluate the safety and immunogenicity of Group A Meningococcal Polysaccharide Conjugate Vaccine produced by Chengdu Institute of Biological Products. Methods In Sheyang County,236 healthy infants aging 3- 4 months were randomly divided into two groups, the control group and the trial group. The trial group were injected Group A Meningococcal Polysaccharide Conjugate Vaccine（GAMPCV）which is produced by Shanghai Institute of Biological Products, while the control group did not. Results The trial Group had no marked systemically side effects.The GMTs of antibodies in trial group both one month after two doses and one month after three doses increased by 4 folds. Antibody positive conversion rate was 100 % in the trial group. The degree of average drop of the antibodies in the trial group increased by 68.48,115.83 folds respectively, which showed significant difference compared with those in the control group （ P 〈0.001）. Conclusion Clinical trial indicated that the ,safety and immunogenicity of Group A Meningococcal Polysaccharide Conjugate Vaccine produced by Chengdu Institute of Biological Products has reached a satisfactory level.
出处
《中国计划免疫》
2006年第5期403-405,共3页
Chinese Journal of Vaccines and Immunization
关键词
A群脑膜炎球菌多糖结合疫苗
安全性
免疫原性
Group A Meningococcal Polysaccharide Conjugate vaccine
Immunogenicity
Safety
Evaluation
