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13价肺炎球菌结合疫苗在预防7至59月龄儿童侵袭性肺炎球菌疾病中的有效性。一项匹配病例对照研究。

Effectiveness of the 13-valent pneumococcal conjugate vaccine in preventing invasive pneumococcal disease in children aged 7-59 months. A matched case-control study.

作者信息

Domínguez Ángela, Ciruela Pilar, Hernández Sergi, García-García Juan José, Soldevila Núria, Izquierdo Conchita, Moraga-Llop Fernando, Díaz Alvaro, F de Sevilla Mariona, González-Peris Sebastià, Campins Magda, Uriona Sonia, Martínez-Osorio Johanna, Solé-Ribalta Anna, Codina Gemma, Esteva Cristina, Planes Ana María, Muñoz-Almagro Carmen, Salleras Luis

机构信息

Departament de Medicina, Universitat de Barcelona, Barcelona, Spain.

CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

出版信息

PLoS One. 2017 Aug 14;12(8):e0183191. doi: 10.1371/journal.pone.0183191. eCollection 2017.

Abstract

BACKGROUND

The 13-valent pneumococcal conjugate vaccine (PCV13) was licensed based on the results of immunogenicity studies and correlates of protection derived from randomized clinical trials of the 7-valent conjugate pneumococcal vaccine. We assessed the vaccination effectiveness (VE) of the PCV13 in preventing invasive pneumococcal disease (IPD) in children aged 7-59 months in a population with suboptimal vaccination coverage of 55%.

METHODS

The study was carried out in children with IPD admitted to three hospitals in Barcelona (Spain) and controls matched by hospital, age, sex, date of hospitalization and underlying disease. Information on the vaccination status was obtained from written medical records. Conditional logistic regression was made to estimate the adjusted VE and 95% confidence intervals (CI).

RESULTS

169 cases and 645 controls were included. The overall VE of ≥1 doses of PCV13 in preventing IPD due to vaccine serotypes was 75.8% (95% CI, 54.1-87.2) and 90% (95% CI, 63.9-97.2) when ≥2 doses before 12 months, two doses on or after 12 months or one dose on or after 24 months, were administered. The VE of ≥1 doses was 89% (95% CI, 42.7-97.9) against serotype 1 and 86.0% (95% CI, 51.2-99.7) against serotype 19A. Serotype 3 showed a non-statistically significant effectiveness (25.9%; 95% CI, -65.3 to 66.8).

CONCLUSIONS

The effectiveness of ≥1 doses of PCV13 in preventing IPD caused by all PCV13 serotypes in children aged 7-59 months was good and, except for serotype 3, the effectiveness of ≥1 doses against the most frequent PCV13 serotypes causing IPD was high when considered individually.

摘要

背景

13价肺炎球菌结合疫苗(PCV13)是根据免疫原性研究结果以及从7价结合肺炎球菌疫苗的随机临床试验得出的保护相关性获得许可的。我们评估了PCV13在疫苗接种覆盖率为55%的次优人群中预防7至59个月儿童侵袭性肺炎球菌病(IPD)的疫苗接种效果(VE)。

方法

该研究在西班牙巴塞罗那三家医院收治的IPD儿童以及按医院、年龄、性别、住院日期和基础疾病匹配的对照组中进行。从书面医疗记录中获取疫苗接种状况信息。采用条件逻辑回归来估计调整后的VE和95%置信区间(CI)。

结果

纳入169例病例和645例对照。在12个月前接种≥2剂、12个月及以后接种2剂或24个月及以后接种1剂时,≥1剂PCV13预防疫苗血清型引起的IPD的总体VE为75.8%(95%CI,54.1 - 87.2)和90%(95%CI,63.9 - 97.2)。≥1剂对1型血清型的VE为89%(95%CI,42.7 - 97.9),对19A血清型的VE为86.0%(95%CI,51.2 - 99.7)。3型血清型显示出无统计学意义的有效性(25.9%;95%CI, - 65.3至66.8)。

结论

≥1剂PCV13在预防7至59个月儿童所有PCV13血清型引起的IPD方面效果良好,除3型血清型外,≥1剂对导致IPD的最常见PCV13血清型单独考虑时有效性较高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad9c/5555701/7839ad97dc70/pone.0183191.g001.jpg

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