An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugate...An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13. 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain-Barré syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)展开更多
目的探讨基质辅助激光解吸电离飞行时间质谱(matrix-assisted laser desorption/ionization time of flight mass spectrometry,MALDI-TOF MS)技术在13价肺炎球菌多糖蛋白结合疫苗生产用菌种质量控制中的作用。方法采用《中国药典》三部...目的探讨基质辅助激光解吸电离飞行时间质谱(matrix-assisted laser desorption/ionization time of flight mass spectrometry,MALDI-TOF MS)技术在13价肺炎球菌多糖蛋白结合疫苗生产用菌种质量控制中的作用。方法采用《中国药典》三部(2020版)中规定方法对13种血清型共24株肺炎球菌的经典表型进行鉴定,应用MALDI-TOF MS技术构建蛋白指纹图谱,根据质谱图的相似性进行聚类分析。同时采用MALDI-TOF MS技术检测不同荚膜丰度14型肺炎球菌(Streptococcus pneumoniae serotype 14,FL14)、不同来源FL5菌种及不同批次FL5工作菌种的蛋白指纹图谱的差异。结果13种血清型肺炎球菌均符合相关要求,蛋白指纹图谱存在差异,共分为3个聚类。不同荚膜丰度FL14的蛋白指纹图谱一致;FL5丹麦菌种及北京儿科医院菌种的指纹图谱有差异,且为不同聚类;不同批次FL5工作菌种的蛋白指纹谱图一致,均为同一个聚类。结论MALDI-TOF MS技术可作为经典细菌表型鉴定外的补充方法,丰富肺炎球菌菌种信息,可应用于疫苗用生产菌种的质量控制。展开更多
文摘An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13. 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain-Barré syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)
文摘目的探讨基质辅助激光解吸电离飞行时间质谱(matrix-assisted laser desorption/ionization time of flight mass spectrometry,MALDI-TOF MS)技术在13价肺炎球菌多糖蛋白结合疫苗生产用菌种质量控制中的作用。方法采用《中国药典》三部(2020版)中规定方法对13种血清型共24株肺炎球菌的经典表型进行鉴定,应用MALDI-TOF MS技术构建蛋白指纹图谱,根据质谱图的相似性进行聚类分析。同时采用MALDI-TOF MS技术检测不同荚膜丰度14型肺炎球菌(Streptococcus pneumoniae serotype 14,FL14)、不同来源FL5菌种及不同批次FL5工作菌种的蛋白指纹图谱的差异。结果13种血清型肺炎球菌均符合相关要求,蛋白指纹图谱存在差异,共分为3个聚类。不同荚膜丰度FL14的蛋白指纹图谱一致;FL5丹麦菌种及北京儿科医院菌种的指纹图谱有差异,且为不同聚类;不同批次FL5工作菌种的蛋白指纹谱图一致,均为同一个聚类。结论MALDI-TOF MS技术可作为经典细菌表型鉴定外的补充方法,丰富肺炎球菌菌种信息,可应用于疫苗用生产菌种的质量控制。
