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10 价肺炎球菌结合疫苗在孟加拉国农村儿童中的放射影像学肺炎有效性:病例对照研究。

Effectiveness of the 10-valent pneumococcal conjugate vaccine against radiographic pneumonia among children in rural Bangladesh: A case-control study.

机构信息

Global Program in Respiratory Sciences, Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, USA; Health Systems Program, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.

Johns Hopkins University - Bangladesh, Dhaka, Bangladesh.

出版信息

Vaccine. 2020 Sep 29;38(42):6508-6516. doi: 10.1016/j.vaccine.2020.08.035. Epub 2020 Aug 29.

Abstract

BACKGROUND

Pneumococcal conjugate vaccine (PCV) effectiveness against radiographic pneumonia in South Asia is unknown. Bangladesh introduced PCV10 in 2015 using a three dose primary series (3 + 0). We sought to measure PCV10 effectiveness for two or more vaccine doses on radiographic pneumonia among vaccine-eligible children in rural Bangladesh.

METHODS

We conducted a matched case-control study over two years from 2015 to 2017 using clinic and community controls in three subdistricts of Sylhet, Bangladesh. Cases were vaccine eligible 3-35 month olds at Upazila Health Complex outpatient clinics with World Health Organization-defined radiographic primary endpoint pneumonia (radiographic pneumonia). Clinic controls were matched to cases within a one week time window by age, sex, and clinic and had an illness unlikely to be Streptococcus pneumoniae; community controls were healthy and similarly matched within a one week time window by age and sex, and distance from the clinic. We estimated adjusted vaccine effectiveness (aVE) using conditional logistic regression.

RESULTS

We matched 1262 cases with 2707 clinic and 2461 community controls. Overall, aVE using clinic controls was 21.4% (95% confidence interval, -0.2%, 38.4%) for ≥2 PCV10 doses and among 3-11 month olds was 47.3% (10.5%, 69.0%) for three doses. aVE increased with higher numbers of doses in clinic control sets (p = 0.007). In contrast, aVE using community controls was 7.6% (95% confidence interval, -22.2%, 30.0%) for ≥2 doses. We found vaccine introduction in the study area faster and less variable than expected with 75% coverage on average, which reduced power. Information bias may also have affected community controls.

CONCLUSIONS

Clinic control analyses show PCV10 prevented radiographic pneumonia in Bangladesh, especially among younger children receiving three doses. While both analyses were underpowered, community control enrollment - compared to clinic controls - was more difficult in a complex, pluralistic healthcare system. Future studies in comparable settings may consider alternative study designs.

摘要

背景

肺炎球菌结合疫苗(PCV)对南亚放射学性肺炎的有效性尚不清楚。孟加拉国于 2015 年使用三剂基础系列(3+0)引入了 PCV10。我们旨在衡量孟加拉国农村地区符合疫苗接种条件的儿童中,两剂或更多 PCV10 剂量对放射学性肺炎的疫苗有效性。

方法

我们在 2015 年至 2017 年期间进行了为期两年的匹配病例对照研究,在孟加拉国的三个分区使用诊所和社区对照。病例是在县卫生综合诊所进行门诊治疗的 3-35 月龄符合世界卫生组织定义的放射学主要终点肺炎(放射学性肺炎)的疫苗接种合格儿童。诊所对照在一周的时间窗口内按年龄、性别和诊所与病例相匹配,且疾病不太可能由肺炎链球菌引起;社区对照在一周的时间窗口内按年龄和性别与病例相匹配,且与诊所的距离相同。我们使用条件逻辑回归估计调整后的疫苗有效性(aVE)。

结果

我们匹配了 1262 例病例与 2707 例诊所对照和 2461 例社区对照。总体而言,使用诊所对照的≥2 剂 PCV10 的 aVE 为 21.4%(95%置信区间,-0.2%,38.4%),3-11 月龄儿童的 aVE 为 47.3%(10.5%,69.0%)。aVE 随诊所对照组中剂量的增加而增加(p=0.007)。相比之下,使用社区对照的≥2 剂的 aVE 为 7.6%(95%置信区间,-22.2%,30.0%)。我们发现研究区域的疫苗接种速度比预期的更快,而且更具变异性,平均覆盖率为 75%,从而降低了效力。信息偏倚也可能影响社区对照。

结论

诊所对照分析表明,PCV10 在孟加拉国预防了放射学性肺炎,尤其是在接受三剂疫苗的年龄较小的儿童中。虽然两种分析都没有足够的效力,但与诊所对照相比,在复杂的多元化医疗保健系统中,社区对照的招募更加困难。在类似环境中进行的未来研究可能会考虑替代研究设计。

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