Baqui Abdullah H, McCollum Eric D, Saha Samir K, Roy Arun K, Chowdhury Nabidul H, Harrison Meagan, Hanif Abu Abdullah Mohammad, Simmons Nicole, Mahmud Arif, Begum Nazma, Ahmed Salahuddin, Khan Ahad M, Ahmed Zabed Bin, Islam Maksuda, Mitra Dipak, Quaiyum Abdul, Chavez Miguel A, Pervaiz Farhan, Miele Catherine H, Schuh Holly B, Khanam Rasheda, Checkley William, Moulton Lawrence H, Santosham Mathuram
Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, 21205, USA.
Department of Pediatrics, Eudowood Division of Pediatric Respiratory Sciences, School of Medicine, Johns Hopkins University, Baltimore, MD, 21205, USA.
Gates Open Res. 2018 Apr 26;2:21. doi: 10.12688/gatesopenres.12805.1.
The study examines the impact of the introduction of 10-valent Pneumococcal Conjugate Vaccine (PCV10) into Bangladesh's national vaccine program. PCV10 is administered to children under 1 year-old; the scheduled ages of administration are at 6, 10, and 18 weeks. The study is conducted in ~770,000 population containing ~90,000 <5 children in Sylhet, Bangladesh and has five objectives: 1) To collect data on community-based pre-PCV incidence rates of invasive pneumococcal diseases (IPD) in 0-59 month-old children in Sylhet, Bangladesh; 2) To evaluate the effectiveness of PCV10 introduction on Vaccine Type (VT) IPD in 3-59 month-old children using an incident case-control study design. Secondary aims include measuring the effects of PCV10 introduction on all IPD in 3-59 month-old children using case-control study design, and quantifying the emergence of Non Vaccine Type IPD; 3) To evaluate the effectiveness of PCV10 introduction on chest radiograph-confirmed pneumonia in children 3-35 months old using incident case-control study design. We will estimate the incidence trend of clinical and radiologically-confirmed pneumonia in 3-35 month-old children in the study area before and after introduction of PCV10; 4) To determine the feasibility and utility of lung ultrasound for the diagnosis of pediatric pneumonia in a large sample of children in a resource-limited setting. We will also evaluate the effectiveness of PCV10 introduction on ultrasound-confirmed pneumonia in 3-35 month-old children using an incident case-control design and to examine the incidence trend of ultrasound-confirmed pneumonia in 3-35 month-old children in the study area before and after PCV10 introduction; and 5) To determine the direct and indirect effects of vaccination status on nasopharyngeal colonization on VT pneumococci among children with pneumonia This paper presents the methodology. The study will allow us to conduct a comprehensive and robust assessment of the impact of national introduction of PCV10 on pneumococcal disease in Bangladesh.
该研究考察了在孟加拉国国家疫苗计划中引入10价肺炎球菌结合疫苗（PCV10）的影响。PCV10用于1岁以下儿童；预定接种年龄为6周、10周和18周。该研究在孟加拉国锡尔赫特约77万人口中开展，其中包含约9万名5岁以下儿童，有五个目标：1）收集孟加拉国锡尔赫特0至59月龄儿童基于社区的侵袭性肺炎球菌疾病（IPD）在引入PCV之前的发病率数据；2）采用病例对照研究设计评估引入PCV10对3至59月龄儿童疫苗型（VT）IPD的有效性。次要目标包括采用病例对照研究设计测量引入PCV10对3至59月龄儿童所有IPD的影响，并对非疫苗型IPD的出现进行量化；3）采用病例对照研究设计评估引入PCV10对3至35月龄儿童胸部X光确诊肺炎的有效性。我们将估计在引入PCV10之前和之后研究地区3至35月龄儿童临床和放射学确诊肺炎的发病率趋势；4）确定在资源有限环境下对大量儿童样本进行肺部超声诊断小儿肺炎的可行性和实用性。我们还将采用病例对照设计评估引入PCV10对3至35月龄儿童超声确诊肺炎的有效性，并考察在引入PCV10之前和之后研究地区3至35月龄儿童超声确诊肺炎的发病率趋势；5）确定疫苗接种状况对肺炎患儿鼻咽部VT肺炎球菌定植的直接和间接影响。本文介绍了研究方法。该研究将使我们能够对在孟加拉国全国引入PCV10对肺炎球菌疾病的影响进行全面而有力的评估。
