From the *Respiratory Diseases Branch, Division of Bacterial Diseases, National Center for Immunizations and Respiratory Diseases; †Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA; ‡International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Westat Inc., Rockville, MD; and ¶Institute of Child Health, University College London, London, United Kingdom.
Pediatr Infect Dis J. 2014 Jan;33 Suppl 2(Suppl 2 Optimum Dosing of Pneumococcal Conjugate Vaccine For Infants 0 A Landscape Analysis of Evidence Supportin g Different Schedules):S140-51. doi: 10.1097/INF.0000000000000082.
Pneumonia is the leading cause of morbidity and mortality among children <5 years of age globally. Pneumococcal conjugate vaccines (PCVs) are known to provide protection against vaccine serotype pneumococcal pneumonia; uncertainty exists regarding the optimum PCV dosing schedule.
We conducted a systematic review of studies published from 1994 to 2010 (supplemented post hoc with studies from 2011) documenting the effect of PCV dosing schedules on clinical and radiologically confirmed pneumonia, pneumococcal pneumonia and empyema among children of ages targeted to receive vaccine. Data on 2- and 3-dose schedules were included. Percent change of pneumonia incidence rates from baseline to most recent year post-PCV introduction was calculated.
We identified 42 primary citations that evaluated PCV schedules and pneumonia. Thirty-seven (88%) were from North America, Europe or Australia; 37 (88%) evaluated PCV7 and 1 (2%) PCV10. Two studies (both observational) compared multiple schedules within the study. We found evidence of reduced clinical and radiologically confirmed pneumonia incidence for all schedules, including 2+1 (1 nonrandomized trial, 5 observational studies), 3+0 (5 randomized trials, 2 observational studies) and 3+1 (5 clinical trials, 24 observational studies) schedules. The magnitude of disease impact did not differ among schedules. Evidence for impact on pneumococcal pneumonia and empyema varied.
All schedules (2+1, 3+0 and 3+1) reduced clinical and radiologically confirmed pneumonia. Quantifying differences in pneumonia disease impact between schedules was difficult due to heterogeneity among studies in design, case definition and population. These findings support World Health Organization recommendations for 3-dose schedules administered as either 3+0 or 2+1 regimens. Pneumonia impact data are still needed on expanded serotype PCV products, developing country settings and the role for a booster dose.
肺炎是全球 5 岁以下儿童发病率和死亡率的主要原因。肺炎球菌结合疫苗(PCV)可有效预防疫苗血清型肺炎球菌肺炎;但 PCV 的最佳剂量方案仍存在不确定性。
我们对 1994 年至 2010 年发表的研究进行了系统评价(事后补充了 2011 年的研究),记录了 PCV 剂量方案对目标接种疫苗儿童的临床和影像学确诊肺炎、肺炎球菌肺炎和脓胸的影响。纳入了 2 剂和 3 剂方案的数据。计算了从 PCV 引入后最近一年到基线的肺炎发病率变化的百分比。
我们确定了 42 篇评估 PCV 方案和肺炎的原始文献。其中 37 篇(88%)来自北美、欧洲或澳大利亚;37 篇(88%)评估了 PCV7,1 篇(2%)评估了 PCV10。两项研究(均为观察性研究)比较了研究内的多种方案。我们发现所有方案,包括 2+1(1 项非随机试验、5 项观察性研究)、3+0(5 项随机试验、2 项观察性研究)和 3+1(5 项临床试验、24 项观察性研究)方案,均降低了临床和影像学确诊肺炎的发生率。方案之间疾病影响的程度没有差异。关于对肺炎球菌肺炎和脓胸影响的证据各不相同。
所有方案(2+1、3+0 和 3+1)都降低了临床和影像学确诊肺炎的发生率。由于研究设计、病例定义和人群的异质性,很难量化不同方案之间肺炎疾病影响的差异。这些发现支持世界卫生组织关于接种 3 剂方案的建议,可采用 3+0 或 2+1 方案。仍需要有关扩展血清型 PCV 产品、发展中国家情况以及加强剂量作用的肺炎影响数据。