10价和13价肺炎球菌结合疫苗对欧洲儿童侵袭性肺炎球菌疾病的有效性：SpIDnet观察性多中心研究
Effectiveness of 10 and 13-valent pneumococcal conjugate vaccines against invasive pneumococcal disease in European children: SpIDnet observational multicentre study.
作者信息
Savulescu Camelia, Krizova Pavla, Valentiner-Branth Palle, Ladhani Shamez, Rinta-Kokko Hanna, Levy Corinne, Mereckiene Jolita, Knol Mirjam, Winje Brita A, Ciruela Pilar, de Miguel Sara, Guevara Marcela, MacDonald Laura, Kozakova Jana, Slotved Hans-Christian, Fry Norman K, Pekka Nuorti J, Danis Kostas, Corcoran Mary, van der Ende Arie, Vestrheim Didrik F, Munoz-Almagro Carmen, Sanz Juan-Carlos, Castilla Jesus, Smith Andrew, Colzani Edoardo, Pastore Celentano Lucia, Hanquet Germaine
机构信息
Epiconcept, Paris, France.
National Institute of Public Health, Prague, Czech Republic.
出版信息
Vaccine. 2022 Jun 23;40(29):3963-3974. doi: 10.1016/j.vaccine.2022.05.011. Epub 2022 May 28.
BACKGROUND
Pneumococcal conjugate vaccines covering 10 (PCV10) and 13 (PCV13) serotypes have been introduced in the infant immunization schedule of most European countries in 2010-11. To provide additional real-life data, we measured the effectiveness of PCV10 and PCV13 against invasive pneumococcal disease (IPD) in children of 12 European sites (SpIDnet).
METHODS
We compared the vaccination status of PCV10 and PCV13 serotype IPD (cases) to that of nonPCV13 serotype IPD (controls) reported in 2012-2018. We calculated pooled effectiveness as (1-vaccination odds ratio)*100, and measured effectiveness over time since booster dose.
RESULTS
The PCV13 and PCV10 studies included 2522 IPD cases from ten sites and 486 cases from four sites, respectively. The effectiveness of ≥ 1 PCV13 dose was 84.2% (95 %CI: 79.0-88.1) against PCV13 serotypes (n = 2353) and decreased from 93.1% (87.8-96.1) < 12 months to 85.1% (72.0-92.1) ≥ 24 months after booster dose. PCV13 effectiveness of ≥ 1 dose was 84.7% (55.7-94.7) against fatal PCV13 IPD, 64.5% (43.7-77.6), 83.2% (73.7-89.3) and 85.1% (67.6-93.1) against top serotypes 3, 19A and 1, respectively, and 85.4% (62.3-94.4) against 6C. Serotype 3 and 19A effectiveness declined more rapidly. PCV10 effectiveness of ≥ 1 dose was 84.8% (69.4-92.5) against PCV10 serotypes (n = 370), 27.2% (-187.6 to 81.6) and 85.3% (35.2-96.7) against top serotypes 1 and 7F, 32.5% (-28.3 to 64.5) and -14.4% (-526.5 to 79.1) against vaccine-related serotypes 19A and 6C, respectively.
CONCLUSIONS
PCV10 and PCV13 provide similar protection against IPD due to the respective vaccine serotype groups but serotype-specific effectiveness varies by serotype and vaccine. PCV13 provided individual protection against serotype 3 and vaccine-related serotype 6C IPD. PCV10 effectiveness was not significant against vaccine-related serotypes 19A and 6C. PCV13 effectiveness declined with time after booster vaccination. This multinational study enabled measuring serotype-specific vaccine effectiveness with a precision rarely possible at the national level. Such large networks are crucial for the post-licensure evaluation of vaccines.
背景
2010 - 2011年，大多数欧洲国家的婴儿免疫计划中引入了覆盖10种血清型（PCV10）和13种血清型（PCV13）的肺炎球菌结合疫苗。为提供更多实际数据，我们在12个欧洲地区（SpIDnet）测量了PCV10和PCV13预防儿童侵袭性肺炎球菌疾病（IPD）的有效性。
方法
我们比较了2012 - 2018年报告的PCV10和PCV13血清型IPD（病例）与非PCV13血清型IPD（对照）的疫苗接种状况。我们将合并有效性计算为（1 - 疫苗接种比值比）×100，并测量自加强剂量后的有效性随时间的变化。
结果
PCV13和PCV10研究分别包括来自10个地区的2522例IPD病例和来自4个地区的486例病例。≥1剂PCV13对PCV13血清型（n = 2353）的有效性为84.2%（95%CI：79.0 - 88.1），且在加强剂量后从<12个月时的93.1%（87.8 - 96.1）降至≥24个月时的85.1%（72.0 - 92.1）。≥1剂PCV13对致命PCV13 IPD的有效性为84.7%（55.7 - 94.7），对血清型3、19A和1这三种主要血清型的有效性分别为64.5%（43.7 - 77.6）、83.2%（73.7 - 89.3）和85.1%（67.6 - 93.1），对6C血清型的有效性为85.4%（62.3 - 94.4）。血清型3和19A的有效性下降得更快。≥1剂PCV10对PCV10血清型（n = 370）的有效性为84.8%（69.4 - 92.5），对血清型1和7F这两种主要血清型的有效性分别为27.2%（-187.6至81.6）和85.3%（35.2 - 96.7），对疫苗相关血清型19A和6C的有效性分别为32.5%（-28.3至64.5）和 - 14.4%（-526.5至79.1）。
结论
PCV10和PCV13针对各自疫苗血清型组提供了类似的针对IPD的保护，但血清型特异性有效性因血清型和疫苗而异。PCV13对血清型3和疫苗相关血清型6C的IPD提供了个体保护。PCV10对疫苗相关血清型19A和6C的有效性不显著。PCV13的有效性在加强疫苗接种后随时间下降。这项多国研究能够精确测量血清型特异性疫苗有效性，这在国家层面很少能做到。如此大规模网络对于疫苗上市后评估至关重要。
Zotero 插件