国产23价肺炎球菌多糖疫苗在≥2岁健康人群中免疫原性和安全性的随机、盲法、对照、非劣效Ⅲ期临床试验  

Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine manufactured in China among a≥2-year-old healthy population:a randomized,blinded,controlled,noninferiority phaseⅢclinical trial

作　　者：莫毅[1] 陈骏籍 黄东 李红[3] 方文建 叶强[3] 杜琳 莫兆军[1] Mo Yi;Chen Junji;Huang Dong;Li Hong;Fang Wenjian;Ye Qiang;Du Lin;Mo Zhaojun(Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention,Nanning 530028,Guangxi,China;Yizhou District Center for Disease Control and Prevention,Hechi 546300,Guangxi,China;National Institutes for Food and Drug Control,Beijing 102629,China;Beijing Zhifeilvzhu Biopharmaceutical co.,Ltd,Beijing 100176,China;Beijing Bacterial Vaccine Engineering Technology Research Center,Beijing 100176,China)

机构地区：[1]广西壮族自治区疾病预防控制中心,广西南宁530028 [2]河池市宜州区疾病预防控制中心,广西河池546300 [3]中国食品药品检定研究院,北京102629 [4]北京智飞绿竹生物制药有限公司,北京100176 [5]北京市细菌性疫苗工程技术研究中心,北京100176

出　　处：《中国疫苗和免疫》2021年第4期403-409,共7页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价一种国产23价肺炎球菌多糖疫苗(PPV23)在≥2岁人群中的免疫原性和安全性。方法采用随机、盲法、平行对照、非劣效Ⅲ期临床试验,在广西壮族自治区招募≥2岁健康受试者,按1∶1比例随机接种1剂国产PPV23(试验组)或已上市的进口PPV23(对照组);检测免疫前和免疫后30d血清中23种肺炎链球菌(Spn)血清型特异性IgG抗体,比较试验组和对照组免疫后抗体阳转率和几何平均浓度(GMC);收集免疫后30d内所有不良事件和6个月内严重不良事件,比较两组不良事件发生率。结果938名试验组和936名对照组受试者接种PPV23后23种Spn血清型IgG抗体阳转率分别为61.19%-98.29%和59.51%-98.18%;两组各血清型抗体阳转率的率差为-6.26%-7.64%,95%CI下限均大于-10%。试验组和对照组免疫后各血清型抗体GMC增长倍数分别为2.81-11.19和2.78-13.16;两组GMC比值为0.82-1.36,95%CI下限均大于0.67。试验组和对照组总不良事件发生率分别为32.56%(309/949)和32.24%(306/949)(Fisher确切概率法,P=0.922)。结论2岁健康人群接种国产PPV23的免疫原性和安全性良好,非劣于已上市的进口PPV23。Objective To evaluate the immunogenicity and safety of a China-manufactured 23-valent pneumococcal polysaccharide vaccine(PPV23)among a≥2-year-old healthy population.Methods We recruited healthy subjects≥2-year-old for a randomized,blinded,parallel-controlled,non-inferiority phase III clinical trial in Guangxi Zhuang Autonomous Region.Subjects were randomly assigned in a 1∶1 ratio to receive either one dose of a domestic PPV23(study group)or a licensed,imported PPV23(control group).We tested sera for IgG antibody against 23 serotypes of Streptococcus pneumoniae(Spn)before and 30 days after vaccination to compare the two groups on seroconversion and geometric mean concentration(GMC).We recorded adverse events for 30 days after vaccination and serious adverse events within 6 months after vaccination to compare adverse event incidences of the two groups.Results IgG seroconversion against 23 Spn serotypes after PPV23 vaccination ranged between 61.19%and 98.29%among the 938 subjects in the study group and between 59.51%and 98.18%among the 936 subjects in the control group.Differences in seroconversion rates between the two groups ranged-6.26%to 7.64%by serotype,with lower limits of all 95%CIs over-10%.Post-vaccination GMCs increased 2.81-11.19 fold in the study group and 2.78-13.16 fold in the control group.GMC ratios of two groups ranged 0.82-1.36 with lower limits of all 95%CIs over 0.67.Overall incidences of adverse events were 32.56%(309/949)in the study group and 32.24%(306/949)in the control group(Fisher’s exact test,P=0.922).Conclusions The domestic PPV23 showed good immunogenicity and safety in a≥2-year-old healthy population and was non-inferior to the licensed,imported PPV23.

关 键 词：肺炎球菌多糖疫苗 免疫原性 安全性 非劣效 Ⅲ期临床试验 

分 类 号：R186[医药卫生—流行病学] R512.62[医药卫生—公共卫生与预防医学]