Quach C, Baclic O
NACI Pneumococcal Working Group Chair, Montréal, QC.
Centre for Immunization and Respiratory Infectious Diseases, Public Health Agency of Canada, Ottawa, ON.
Can Commun Dis Rep. 2016 Dec 1;42(12):260-262. doi: 10.14745/ccdr.v42i12a05.
Since 2015, pneumococcal 13-valent conjugate vaccine (PNEU-C-13) has been authorized for the prevention of invasive pneumococcal disease (IPD) and pneumococcal community-acquired pneumonia (CAP) in adults. Adults with immunocompromising conditions are still recommended to receive PNEU-C-13 followed by the pneumococcal 23-valent polysaccharide vaccine (PNEU-P-23). NACI guidance has been requested on the use of PNEU-C-13 vaccine in immunocompetent adults 65 years of age and older.
To make recommendations, at the individual level, for the use of PNEU-C-13 in immunocompetent adults 65 years of age and over.
The NACI Pneumococcal Working Group (PWG) reviewed key questions and performed an evidence review and synthesis. In consideration of the burden of illness to be prevented, the target population, safety, immunogenicity, efficacy and effectiveness of the vaccine, the PWG proposed recommendations for vaccine use to NACI. All evidence was rated and reported in evidence tables. NACI approved specific evidence-based recommendations and elucidated the rationale and relevant considerations in the statement update.
NACI identified and reviewed evidence from one randomized controlled trial investigating the efficacy of PNEU-C-13 to prevent IPD and CAP in adults who were immunocompetent at enrollment and three clinical trials assessing the immunogenicity in immunocompetent and immunocompromised adults.
Based on reviewed evidence, NACI issued new recommendations for the use of pneumococcal vaccines in immunocompetent adults 65 years of age and older.
自2015年以来,13价肺炎球菌结合疫苗(PNEU-C-13)已被批准用于预防成人侵袭性肺炎球菌病(IPD)和肺炎球菌社区获得性肺炎(CAP)。仍建议免疫功能低下的成人接种PNEU-C-13,随后接种23价肺炎球菌多糖疫苗(PNEU-P-23)。已就65岁及以上免疫功能正常的成年人使用PNEU-C-13疫苗事宜征求了加拿大国家免疫咨询委员会(NACI)的指导意见。
针对65岁及以上免疫功能正常的成年人使用PNEU-C-13疫苗提出个体化建议。
NACI肺炎球菌工作组(PWG)审查了关键问题,并进行了证据审查和综合分析。考虑到要预防的疾病负担、目标人群、疫苗的安全性、免疫原性、有效性和效果,PWG向NACI提出了疫苗使用建议。所有证据均进行了评级并在证据表中报告。NACI批准了基于证据的具体建议,并在声明更新中阐明了理由和相关考虑因素。
NACI识别并审查了一项随机对照试验的证据,该试验调查了PNEU-C-13在入组时免疫功能正常的成年人中预防IPD和CAP的疗效,以及三项评估免疫功能正常和免疫功能低下成年人免疫原性的临床试验。
基于审查的证据,NACI发布了关于65岁及以上免疫功能正常的成年人使用肺炎球菌疫苗的新建议。