Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults
Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults
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DOI：
10.1056/nejmoa1408544
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发表时间：
2015-03-19
影响因子：
158.5
通讯作者：
Grobbee, D. E.
中科院分区：
文献类型：
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作者：
Bonten, M. J. M.;Huijts, S. M.;Grobbee, D. E.
肺炎球菌多糖结合疫苗可预防婴儿肺炎球菌疾病，但其对65岁及以上成人肺炎球菌社区获得性肺炎的有效性尚不清楚。方法在一项随机、双盲、安慰剂对照试验中，我们评估了13价多糖结合疫苗（PCV13）在预防疫苗型肺炎球菌性社区获得性肺炎、非菌血症性和非侵袭性肺炎球菌性社区获得性肺炎和侵袭性肺炎球菌病首次发作中的疗效。采用标准的实验室方法和血清型特异性尿抗原检测法鉴定社区获得性肺炎和侵袭性肺炎球菌病。结果在疫苗型毒株首次感染的方案分析中，PCV13组49人发生社区获得性肺炎，安慰剂组90人发生社区获得性肺炎（疫苗有效性，45.6%；95.2%可信区间[CI]， 21.8 ~ 62.5）， PCV13组33人发生非菌源性和非侵入性社区获得性肺炎，安慰剂组60人(疫苗有效性，45.0%；PCV13组有7人发生侵袭性肺炎球菌疾病，安慰剂组有28人发生侵袭性肺炎球菌疾病（疫苗有效性，75.0%;95% CI， 41.4至90.8）。疗效持续整个试验（平均随访3.97年）。在改良意向治疗分析中，观察到相似的疗效（疫苗疗效，分别为37.7%、41.1%和75.8%），PCV13组和安慰剂组分别有747人和787人发生了社区获得性肺炎（疫苗疗效，5.1%;95% CI, -5.1至14.2）。两组严重不良事件和死亡人数相似，但PCV13组局部反应较多。结论在老年人中，PCV13对预防疫苗型肺炎球菌、菌血症和非菌血症性社区获得性肺炎和疫苗型侵袭性肺炎球菌病有效，但对预防任何原因的社区获得性肺炎无效。
BACKGROUNDPneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown.METHODSIn a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease.RESULTSIn the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% confidence interval [CI], 21.8 to 62.5), nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group (vaccine efficacy, 45.0%; 95.2% CI, 14.2 to 65.3), and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group (vaccine efficacy, 75.0%; 95% CI, 41.4 to 90.8). Efficacy persisted throughout the trial (mean follow-up, 3.97 years). In the modified intention-totreat analysis, similar efficacy was observed (vaccine efficacy, 37.7%, 41.1%, and 75.8%, respectively), and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group (vaccine efficacy, 5.1%; 95% CI, -5.1 to 14.2). Numbers of serious adverse events and deaths were similar in the two groups, but there were more local reactions in the PCV13 group.CONCLUSIONSAmong older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccine-type invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause.