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PCV-10 和 PCV-13 疫苗预防侵袭性肺炎球菌病的效果和效力。

Efficacy and Effectiveness of the PCV-10 and PCV-13 Vaccines Against Invasive Pneumococcal Disease.

机构信息

Department of Epidemiology, Biostatistics, and Occupational Health and.

Vaccine Study Centre, Research Institute of the McGill University Health Centre, McGill University, Montreal, Quebec, Canada.

出版信息

Pediatrics. 2020 Apr;145(4). doi: 10.1542/peds.2019-0377. Epub 2020 Mar 10.

DOI:10.1542/peds.2019-0377
PMID:32156773
Abstract

CONTEXT

Pneumococcal conjugate vaccines (PCVs) (pneumococcal 13-valent conjugate vaccine [PCV-13] and pneumococcal 10-valent conjugate vaccine [PCV-10]) are available for prevention of pneumococcal infections in children.

OBJECTIVE

To determine the vaccine effectiveness (VE) of PCV-13 and PCV-10 in preventing invasive pneumococcal disease (IPD) and acute otitis media (AOM) in children <5 years.

DATA SOURCES

Systematic searches of Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Cochrane.

STUDY SELECTION

Eligible studies examined the direct effectiveness and/or efficacy of PCV-10 and PCV-13 in reducing the incidence of disease in healthy children <5 years.

DATA EXTRACTION

Two reviewers independently conducted data extraction and methodologic quality assessment.

RESULTS

Significant effectiveness against vaccine-type IPD in children ≤5 years was reported for ≥1 dose of PCV-13 in the 3 + 1 (86%-96%) and 2 + 1 schedule (67.2%-86%) and for PCV-10 for the 3 + 1 (72.8%-100%) and 2 + 1 schedules (92%-97%). In children <12 months of age, PCV-13 VE against serotype 19A post-primary series was significant for the 3 + 1 but not the 2 + 1 schedule. PCV-10 crossprotection against 19A was significant in children ≤5 years with ≥1 dose (82.2% and 71%). Neither PCVs were found effective against serotype 3. PCV-13 was effective against AOM (86%; 95% confidence interval [CI]: 61 to 94). PCV-10 was effective against clinically defined (26.9%; 95% CI: 5.9 to 43.3) and bacteriologically confirmed AOM (43.3%; 95% CI: 1.7 to 67.3).

LIMITATIONS

Because of the large heterogeneity in studies, a meta-analysis for pooled estimates was not done.

CONCLUSIONS

Both PCVs afford protection against pneumococcal infections, with PCV-10 protecting against 19A IPD, but this VE has not been verified in the youngest age groups.

摘要

背景

肺炎球菌结合疫苗(PCV)(肺炎球菌 13 价结合疫苗[PCV-13]和肺炎球菌 10 价结合疫苗[PCV-10])可用于预防儿童肺炎球菌感染。

目的

确定 PCV-13 和 PCV-10 预防 5 岁以下儿童侵袭性肺炎球菌病(IPD)和急性中耳炎(AOM)的疫苗有效性(VE)。

数据来源

系统检索 Medline、Embase、护理与联合健康文献累积索引、Web of Science 和 Cochrane。

研究选择

合格的研究检查了 PCV-10 和 PCV-13 在降低 5 岁以下健康儿童疾病发病率方面的直接有效性和/或功效。

数据提取

两名审查员独立进行数据提取和方法学质量评估。

结果

在≥1 剂 3+1(86%-96%)和 2+1 方案(67.2%-86%)中,3+1 方案(72.8%-100%)和 2+1 方案(92%-97%)中报告了对≤5 岁儿童疫苗型 IPD 的显著有效性。在<12 个月龄的儿童中,PCV-13 对初级系列后血清型 19A 的 VE 在 3+1 方案中显著,但在 2+1 方案中不显著。在≥1 剂 PCV-10 中,对≤5 岁儿童的 19A 具有交叉保护作用(82.2%和 71%)。两种 PCV 均不能有效预防血清型 3。PCV-13 对 AOM 有效(86%;95%置信区间[CI]:61 至 94)。PCV-10 对临床定义的(26.9%;95%CI:5.9 至 43.3)和细菌学确诊的 AOM(43.3%;95%CI:1.7 至 67.3)有效。

局限性

由于研究之间存在很大的异质性,因此未对汇总估计值进行荟萃分析。

结论

两种 PCV 均可提供针对肺炎球菌感染的保护,PCV-10 可预防 19A IPD,但这种 VE 尚未在年龄最小的人群中得到证实。

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