摘要
目的 比较Ⅰ＋Ⅲ型脊髓灰质炎减毒活疫苗（人二倍体细胞）（bOPV）糖丸和液体剂型与Sabin株脊髓灰质炎灭活疫苗（sIPV）联合序贯免疫接种在≥2月龄婴儿中的免疫原性和安全性.方法于2015年9月至2016年6月,采用随机、盲法、单中心、平行对照设计,选择广西柳州市≥2月龄的婴儿为研究对象,将其分为1sIPV＋2bOPV和2sIPV＋1bOPV组,每种序贯免疫程序按bOPV剂型不同再分为糖丸剂型组与液体剂型组,即1sIPV＋2bOPV糖丸组、1sIPV＋2bOPV液体组、2sIPV＋1bOPV糖丸组、2sIPV＋1bOPV液体组,每组100名,按照0、28、56 d的免疫程序,共接种3剂.记录至少接种1剂次受试者（399名）不良反应事件;全程免疫后28 d,采集排除脱落者和违背试验方案者（共350名）血样,采用细胞培养微量中和试验测定抗脊灰病毒Ⅰ、Ⅱ、Ⅲ型中和抗体滴度（GMT）,计算抗体阳转率,并对其进行统计学分析.结果1sIPV＋2bOPV糖丸组、1sIPV＋2bOPV液体组、2sIPV＋1bOPV糖丸组、2sIPV＋1bOPV液体组全部不良反应发生率分别为79%（79/100）、76%（76/100）、80%（79/99）和74%（74/100） （χ2=1.23,P=0.747）;严重不良反应发生率分别为6%（6/100）、5%（5/100）、6%（6/99）和4%（4/100）（χ2=0.57,P=0.903）.全程免疫后,1sIPV＋2bOPV糖丸组、1sIPV＋2bOPV液体组、2sIPV＋1bOPV糖丸组、2sIPV＋1bOPV液体组Ⅰ型脊灰抗体阳转率分别为99%（86/87）、100%（83/83）、99%（87/88）、99%（91/92）（χ2=0.94,P=0.815）,Ⅱ型分别为47%（41/87）、57%（47/83）、80%（70/88）、79%（73/92）（χ2=31.56,P〈0.001）,Ⅲ型分别为100%（87/87）、99%（82/83）、100%（88/88）、99%（91/92）（χ2=2.02,P=0.568）;Ⅰ型脊灰抗体GMT分别为4539.68、6243.43、6819.53、7916.29（F=25.87,P〈0.001）,Ⅱ型分别为12.98、10.54、63.75、84.21（F=8.68,P=0.034）,Ⅲ型分别为1172.55、1416.03、2648.89、3250.75（F=14.50,P=0.002）.结论 相同序贯免疫程序中,bOPV
Objective To compare the safety and immunogenicity of two different sequential schedules of inactivated poliomyelitis vaccine made from Sabin strain（sIPV）followed by typeⅠ＋Ⅲbivalent oral poliovirus vaccine（bOPV）in Drug Candy （DC） form or liquid dosage form）. Methods This randomized, blinded, single center, parallel-group controlled trial was done from September 2015 to June 2016 in Liuzhou, Guangxi province. Healthy infants aged ≥2 months were eligible for enrollment and divided into 1sIPV＋2bOPV or 2sIPV＋1bOPV sequential schedules. According to the bOPV dosage form each sequential schedules,the subjects again were divided into drug candy（DC）form or liquid dosage form group, being 1sIPV＋bOPV （DC）/ 1sIPV＋2bOPV（ liquid）/2sIPV＋1bOPV（DC）/2sIPV＋1bOPV（liquid）. According to 0, 28, 56 d immunization schedule, Each group were given 3 doses. We recorded adverse events during the clinical trial （399 participants who receive at least one dose）. 28 days post-Dose 3, we receive a total of 350 blood samples（excluding the quitters or subjects against trial plan）,using cell culture trace against polio virus neutralization testⅠ,Ⅱ,Ⅲneutralizing antibody（GMT）,calculating the antibody positive rate.PolioⅠ,Ⅱand Ⅲ antibody titers were assessed by virus-neutralizing antibody assay and the seroconversion （4-fold increase in titer） from pre-Dose 1 to 28 days post-Dose 3 was calculated（total 350 samples）. Results During the vaccination, the incidence of AEs in 1sIPV＋2bOPV（DC）, 1sIPV＋2bOPV （liquid）,2sIPV＋1bOPV（DC）,2sIPV＋1bOPV（liquid）group were 79%,76%,80% and 74%（χ2=1.23,P=0.747）,respectively. The severe AEs in groups were 6%, 5%, 6% and 4%（χ2=0.57,P=0.903）, respectively, and none was considered to be vaccination related. 28 days after 3rd vaccination, the seroconversion rates in 1sIPV＋2bOPV（DC）,1sIPV＋2bOPV（liquid）,2sIPV＋1bOPV（DC）,2sIPV＋1bOPV （liquid） group, were 99%, 100%, 99% and 99%（χ2=0.94,P=
出处
《中华预防医学杂志》
CAS
CSCD
北大核心
2018年第1期43-49,共7页
Chinese Journal of Preventive Medicine
