多糖结合疫苗预防成人肺炎球菌性肺炎。
Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults.
机构信息
From the Julius Center for Health Sciences and Primary Care (M.J.M.B., S.M.H., M.B., C.H.W., A.M.M.D., T.J.M.V.) and the Department of Medical Microbiology (M.J.M.B., S.M.H., M.B., C.H.W., A.M.M.D., T.J.M.V.), University Medical Center (UMC) Utrecht, and the Department of Immunology and Infectious Diseases, Wilhelmina Children's Hospital, UMC Utrecht (A.M.M.D., E.A.M.S.), Utrecht, Research Center Linnaeus Institute, Spaarne Hospital, Hoofddorp (A.M.M.D.), and Julius Clinical, Zeist (R.L., B.O., N.V., E.C., A.S., D.E.G.) - all in the Netherlands; Pfizer Vaccine Clinical Research, Maidenhead, United Kingdom (C.W., S.G., M.P., A.M., A.M.-H., H.S., T.M., G.C.); Pfizer Vaccine Clinical Research, Collegeville, PA (S.P., E.A.E.); Pfizer Vaccine Research and Early Development (M.W.P., K.U.J.) and Pfizer Vaccine Clinical Research (D.A.S., E.A.E., W.C.G.), Pearl River, NY; and Pfizer Vaccine Clinical Research, Berlin (B.S.-T.).
出版信息
N Engl J Med. 2015 Mar 19;372(12):1114-25. doi: 10.1056/NEJMoa1408544.
BACKGROUND
Pneumococcal 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.
METHODS
In 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.
RESULTS
In 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-to-treat 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.
CONCLUSIONS
Among 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. (Funded by Pfizer; CAPITA ClinicalTrials.gov number NCT00744263.).
背景
肺炎球菌多糖结合疫苗可预防婴幼儿肺炎球菌病，但对于 65 岁及以上成年人的社区获得性肺炎的疗效尚不清楚。
方法
在一项涉及 84496 名 65 岁及以上成年人的随机、双盲、安慰剂对照试验中，我们评估了 13 价肺炎球菌多糖结合疫苗（PCV13）预防疫苗型肺炎球菌社区获得性肺炎、非菌血症性和非侵袭性肺炎球菌社区获得性肺炎以及侵袭性肺炎球菌病的疗效。采用标准实验室方法和血清型特异性尿抗原检测法来确定社区获得性肺炎和侵袭性肺炎球菌病。
结果
在针对疫苗型菌株初次感染的方案分析中，PCV13 组有 49 例发生社区获得性肺炎，安慰剂组有 90 例（疫苗效力为 45.6%；95%置信区间[CI]为 21.8%至 62.5%），PCV13 组有 33 例发生非菌血症性和非侵袭性社区获得性肺炎，安慰剂组有 60 例（疫苗效力为 45.0%；95%CI 为 14.2%至 65.3%），PCV13 组有 7 例发生侵袭性肺炎球菌病，安慰剂组有 28 例（疫苗效力为 75.0%；95%CI 为 41.4%至 90.8%）。疗效在整个试验期间持续存在（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（疫苗效力分别为 37.7%、41.1%和 75.8%），PCV13 组有 747 例发生社区获得性肺炎，安慰剂组有 787 例（疫苗效力为 5.1%；95%CI 为-5.1%至 14.2%）。两组严重不良事件和死亡的数量相似，但 PCV13 组的局部反应更多。
结论
在老年人中，PCV13 可有效预防疫苗型肺炎球菌、菌血症性和非菌血症性社区获得性肺炎以及疫苗型侵袭性肺炎球菌病，但不能预防任何原因引起的社区获得性肺炎。（由辉瑞公司资助；CAPITA ClinicalTrials.gov 编号：NCT00744263。）
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