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目的系统评价儿童接种含A群、C群组分的国产脑膜炎球菌疫苗的免疫原性。方法检索美国国家医学图书馆数据库、中国期刊全文数据库、万方全文数据库等,筛选出有关含A群、C群组分的国产脑膜炎球菌疫苗免疫原性的研究。以血清杀菌力试验(serum bactericidal activity,SBA)检测儿童接种1剂次或2剂次脑膜炎球菌疫苗的血清抗体阳转率(seroconversion rate,SR)作为结局指标,采用R 3.2.0软件合并所有单个研究的SR和对照研究的抗体阳转率率差(risk difference,RD),按异质性判定标准选择M-H法(maenszel-haenszel)分析的固定效应模型结果和D-L法(dersimonian-laird)分析的随机效应模型结果。结果纳入23篇文献,7篇为脑膜炎球菌多糖疫苗(meningococcal polysaccharide vaccine,MPSV)和脑膜炎球菌多糖结合疫苗(meningococcal polysaccharide-protein conjugate vaccine,MPCV)比较的对照研究,其余均为非对照研究。2岁儿童接种2剂次MPSV后A群和C群的SR分别为78.54%和62.82%。2~15岁儿童接种1剂MPSV后A群和C群的SR分别为94.25%和94.71%;2岁儿童接种2剂次MPCV后A群和C群的SR分别为98.78%和98.44%;2~15岁儿童接种1剂次MPCV后A群和C群的SR分别为98.54%和97.79%。在MPSV和MPCV比较研究中,2岁的儿童接种2剂次后A群的抗体阳转率RD为0.19(95%CI:0.03~0.35);2~15岁接种1剂次后A群和C群抗体阳转率RD分别为0.05(95%CI:-0.01~0.11)和0.06(95%CI:-0.06~0.17)。结论 2岁儿童接种含A群、C群组分MPCV的免疫原性优于同组分的MPSV,含A群、C群组分的MPSV和MPCV均可在2~15岁儿童中产生良好的免疫原性。
Objective To systematically evaluate the immunogenicity of domestic inoculated meningococcal vaccine containing group A and group C children. Methods The databases of the National Library of Medicine of China, Chinese Journal Full-text Database and Wanfang Full-text Database were searched and the immunogenicity of domestic meningococcal vaccine containing A group and C group was screened out. Serum antibody seroconversion rate (SR) in children vaccinated with one or two doses of meningococcal vaccine was determined by serum bactericidal activity (SBA) as a measure of outcome, using R 3.2.0 software to combine all In a single study, the risk difference (RD) for SR and control studies, the fixed effect model results for the maenszel-haenszel analysis based on the criteria for heterogeneity, and the dersimonian-laird analysis Random effects model results. Results A total of 23 articles were included, of which 7 were comparative studies comparing meningococcal polysaccharide vaccine (MPSV) and meningococcal polysaccharide-protein conjugate vaccine (MPCV). The rest were non-controlled studies. The SR of group A and group C after 2 doses of MPSV were 78.54% and 62.82%, respectively. The SR of group A and group C were 94.25% and 94.71% respectively after 2 doses of MPSV were administered to children aged 2-15 years. The SRs of group A and group C were 98.78% and 98.44% respectively after 2 doses of 2-year-old children were inoculated with 2 doses of MPCV. 2 The SR of group A and group C were 98.54% and 97.79% respectively for 15-year-old children receiving one dose of MPCV. In the comparative study of MPSV and MPCV, the antibody positive conversion rate (RD) of group A was 0.19 (95% CI: 0.03-0.35) after 2 doses of 2-year-old children. After group A and group C The positive rate of population antibody RD was 0.05 (95% CI: -0.01 ~ 0.11) and 0.06 (95% CI: -0.06 ~ 0.17) respectively. Conclusions The immunogenicity of 2-year-old children vaccinated with group A and group C MPCV is better than that of the same group of MPSV. MPSV and MPCV containing group A and group C can produce good Immunogenicity.