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沈嘉铭, 刘肖飞, 黄莉莉, 陶云珍, 郑本锋, 赵根明, 田健美, 栾琳, 邵雪君, 张涛. 检测阴性设计病例对照研究评价23价肺炎球菌多糖疫苗的儿童保护效果[J]. 中国公共卫生, 2023, 39(11): 1430-1437. DOI: 10.11847/zgggws1141850
引用本文: 沈嘉铭, 刘肖飞, 黄莉莉, 陶云珍, 郑本锋, 赵根明, 田健美, 栾琳, 邵雪君, 张涛. 检测阴性设计病例对照研究评价23价肺炎球菌多糖疫苗的儿童保护效果[J]. 中国公共卫生, 2023, 39(11): 1430-1437. DOI: 10.11847/zgggws1141850
SHEN Jiaming, LIU Xiaofei, HUANG Lili, TAO Yunzhen, ZHENG Benfeng, ZHAO Genming, TIAN Jianmei, LUAN Lin, SHAO Xuejun, ZHANG Tao. Effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumococcal disease in children with acute respiratory illness: a hospital- based test-negative design study[J]. Chinese Journal of Public Health, 2023, 39(11): 1430-1437. DOI: 10.11847/zgggws1141850
Citation: SHEN Jiaming, LIU Xiaofei, HUANG Lili, TAO Yunzhen, ZHENG Benfeng, ZHAO Genming, TIAN Jianmei, LUAN Lin, SHAO Xuejun, ZHANG Tao. Effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumococcal disease in children with acute respiratory illness: a hospital- based test-negative design study[J]. Chinese Journal of Public Health, 2023, 39(11): 1430-1437. DOI: 10.11847/zgggws1141850

检测阴性设计病例对照研究评价23价肺炎球菌多糖疫苗的儿童保护效果

Effectiveness of 23-valent pneumococcal polysaccharide vaccine against pneumococcal disease in children with acute respiratory illness: a hospital- based test-negative design study

  • 摘要:
      目的   采用检测阴性设计病例对照研究评价23价肺炎球菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine, PPV23)对儿童肺炎球菌即肺炎链球菌(Streptococcus pneumonia, Spn)相关呼吸道感染疾病的保护效果。
      方法   选取2017年1月1日 — 2020年12月31日因急性呼吸道感染(acute respiratory illness, ARI)在苏州大学附属儿童医院住院治疗的2岁 ≤ 年龄 < 10岁的患儿为研究对象,前瞻性收集呼吸道感染患儿中分离的肺炎链球菌菌株,通过荚膜肿胀实验确定 Spn菌株血清型。采用检测阴性设计病例对照研究,病例组为感染PPV23血清型肺炎球菌的患儿,对照组分别为非疫苗血清型(non-vaccine serotype,NVT)患儿(感染非PPV23血清型肺炎球菌患儿)(NVT对照组)和肺炎球菌阴性(Spn –)患儿(临床样本中未检出感染Spn的患儿)(Spn – 对照组)。在苏州市疾病预防控制中心的疫苗接种登记数据库中查询患儿 PPV23接种的相关信息。采用Logistic回归模型估计PPV23接种的调整比值比,评价PPV23的保护效果(vaccine effectiveness, VE)。
      结果   共纳入1 749株Spn菌株,其最常见的血清型依次为19F、6B、23F、6A 和19A;PCV13和PPV23疫苗血清型覆盖率分别为76.56%和72.27%。病例组共纳入1 264例患儿、NVT对照组485例、Spn – 对照组1 590例,平均年龄分别为(3.88 ± 1.27)、(4.02 ± 1.43)、(4.52 ± 1.92)岁;病例组、NVT对照组和Spn – 对照组PPV23的接种率分别为5.4%、6.8%和5.8%,接种疫苗的平均年龄为(2.53 ± 0.61)岁。以NVT患儿为对照时,通过logistic回归模型调整患儿年龄、临床诊断和其他疫苗接种情况后,PPV23对预防儿童疫苗血清型Spn肺炎球菌相关呼吸道感染疾病的总体保护效果(VE)为18.3%(95%CI = – 26.3%~47.1%),对社区获得性肺炎的VE为15.7%,对血清型19F、6B及15B的VE分别为32.8%、16.5%和57.5%,对2~5岁儿童的保护效果(26.0%)优于5岁以上儿童(7.6%)。以Spn – 患儿为对照时,通过logistic回归模型调整患儿年龄、户籍、其他疫苗接种情况、就诊年份、就诊季节及临床诊断后,PPV23对2~5岁儿童的保护效果为29.9%(95%CI = – 22.0%~59.7%)。
      结论   PPV23对预防儿童疫苗血清型Spn相关呼吸道感染疾病具有一定的保护效果,但随接种后时间的推移而减弱。

     

    Abstract:
      Objective  To assess the effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPV23) against Streptococcus pneumonia (Spn)-associated respiratory tract infection in children with a test-negative design study.
      Methods  We recruited totally 3 339 children at ages of 2 – 9 years hospitalized due to acute respiratory illness (ARI) and being detected for Spn isolates in sputum/bronchoalveolar lavage fluid (BALF) during 2017 – 2020 at the Soochow University Affiliated Children's Hospital for a test-negative case-control design study. The collected Spn isolates were serotyped with Quellung test. Of the all the participants, 1 264 being positive for PPV23 serotype Spn (VT-Spn) in sputum/BALF specimens were assigned into a case group; the two control groups were 485 being positive for non-PPV23 serotype (NVT-Spn) and 1 590 being negative for Spn (Spn –). The participants′ information on PPV23 vaccination were collected from the Vaccination Registry Database of Suzhou Municipal Center for Disease Control and Prevention. The adjusted odds ratio of PPV23 vaccination was calculated with logistic regression model to estimate the vaccine effectiveness (VE) of PPV23 against Spn-associated ARI.
      Results  Among the 1 749 Spn strains isolated, the most common serotypes were 19F, 6B, 23F, 6A and 19A; 76.56% and 72.27% were positive for 13-valent pneumococcal conjugate vaccine (PCV13) serotype and PPV23 serotype, respectively. For the participants of VT-Spn, NVT-Spn and Spn – group, the mean age were 3.88 ± 1.27, 4.02 ± 1.43, and 4.52 ± 1.92 years; the vaccination rate of PPV23 were 5.4%, 6.8%, and 5.8%, respectively; and the mean age at the vaccination was 2.53 ± 0.61 years for all the participants vaccinated., When using the NVT-Spn group as the control and after adjusting for age, clinical diagnosis, and other vaccination status, the logistic regression analysis revealed an overall PPV23 effectiveness of 18.3% (95% confidence interval 95%CI: – 26.3% – 47.1%) for against Spn-associated ARI, an effectiveness of 15.7% for against community acquired pneumonia, and the effectiveness of 32.8, 16.5% and 57.5% for against serotype 19F, 6B and 15B Spn-associated ARI, respectively, and the effectiveness (26.0%) was better in the participants aged 2 – 5 years than that (7.6%) in those aged older than 5 year; while using the Spn – group as the control and after adjusting for age, household registration, other vaccination status, the year of seeking medication, season of seeking medication, and clinical diagnosis, the logistic regression analysis showed a VE of 29.9% (95% CI: – 22.0% – 59.7%) for the participants aged 2 – 5 years.
      Conclusion   PPV23 is of certain protection against Spn-associated respiratory tract infections in 2 – 9 years old children and the effectiveness decreases with the prolonged time after receiving the vaccination

     

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