A群C群脑膜炎球菌多糖结合疫苗的安全性及免疫原性分析

Safety and immunogenicity analysis of group A and group C meningococcal p olysaccharide conjugate vaccine

目的:探讨并分析婴幼儿接种A群C群脑膜炎球菌多糖结合疫苗的安全性及免疫原性。方法:选取115名接种A群C群脑膜炎球菌多糖结合疫苗的婴幼儿作为研究对象,观察其接种疫苗后的表现,根据其出现全身或局部不良反应的情况评价该疫苗的安全性。在接种疫苗前及接种疫苗后30 d,检测并评价婴幼儿的免疫原性。结果:接种A群C群脑膜炎球菌多糖结合疫苗前,这115名婴幼儿A群流脑抗体的阳性率和C群流脑抗体的阳性率分别为2.61%和6.09%,几何平均滴度(GMT)分别为4.30和4.38。接种A群C群脑膜炎球菌多糖结合疫苗后30 d,这115名婴幼儿A群流脑抗体的阳性率和C群流脑抗体的阳性率分别为95.65%和97.39%,GMT分别为162.27和157.39。这115名婴幼儿接种A群C群脑膜炎球菌多糖结合疫苗后出现的不良反应有发热、腹泻、皮肤斑丘疹、皮肤瘙痒、皮肤水泡疹等,其上述不良反应多较为轻微。结论:为婴幼儿接种A群C群脑膜炎球菌多糖结合疫苗具有良好的安全性及免疫原性。

Objective:To investigate and analyze the safety and immunogenicity of group A and group C meningococcal polysaccharide conjugate vaccine in infants.Methods:A total of 115 infants and young children who were vaccinated with group A and group C meningococcal polysaccharide conjugate vaccine were selected as research subjects,and their performance after vaccination was observed.The safety of the vaccine was evaluated according to the occurrence of systemic or local adverse reactions.Immunogenicity of infants and young children was measured and evaluated before and 30 days after vaccination.Results:Before inoculation with group A and group C meningococcal polysaccharide conjugate vaccine,the positive rates of group A and group C meningococcal antibody were 2.61%and 6.09%,respectively,and the geometric mean titer(GMT)were 4.30 and 4.38,respectively.At 30 days after inoculation with group A and group C meningococcal polysaccharide conjugate vaccine,the positive rates of group A and group C meningococcal antibody in the 115 infants were 95.65%and 97.39%,respectively,162.27 and 157.39 GMT.The adverse reactions of the 115 infants inoculated with group A and group C meningococcal polysaccharide conjugate vaccine were fever,diarrhea,skin maculopapule,skin pruritus,skin blister rash,etc.,and the above adverse reactions were mostly mild.Conclusion:Group A and group C meningococcal polysaccharide conjugate vaccine for infants has good safety and immunogenicity.