The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
The Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel.
Clin Infect Dis. 2021 Aug 16;73(4):650-658. doi: 10.1093/cid/ciab066.
Despite the demonstrated impact of pneumococcal vaccine (PCV) implementation on otitis media (OM), demonstration of real-life serotype-specific effectiveness of the 7-valent and 13-valent PCVs (PCV7 and PCV13) is lacking owing to the paucity of culture-positive cases. Furthermore, prelicensure PCV13 efficacy against OM was not studied.
The study was conducted from October 2009 to July 2013. Case patients were children aged 5-35 months with OM (mostly complex OM [recurrent/nonresponsive, spontaneously draining, chronic with effusion]) from whom middle-ear fluid culture was obtained; controls were contemporary children with rotavirus-negative gastroenteritis in a prospective population-based rotavirus surveillance, from the same age group with similar ethnic distribution and geographic location. Vaccine effectiveness (VE) was estimated as 1 minus the odds ratio using unconditional logistic regression, adjusting for time since PCV implementation, age, and ethnicity.
A total of 223 case patients and 1370 controls were studied. Serotypes 19F and 19A together caused 56.1% of all vaccine-type (VT) OM. VE of ≥2 PCV doses in children aged 5-35 months was demonstrated as follows: PCV7 against OM due to PCV7 serotypes, 57.2% (95% confidence interval, 6.0%-80.5%); PCV13 against OM due to PCV13 serotypes, 77.4% (53.3%-92.1%); PCV13 against OM due to the 6 additional non-PCV7 serotypes 67.4% (17.6%-87.1%); PCV13 against OM due to serotype 19F, 91.3% (1.4%-99.2%); and PCV13 against OM due to serotype 3, 85.2% (23.9%-98.4%). PCV7 and PCV13 VE against OM due to serotype 19A in children aged 12-35 months was 72.4% (95% confidence interval, 6.2%-91.9%) and 94.6% (33.9%-99.6%), respectively.
PCV7 and PCV13 were effective against complex OM caused by the targeted serotypes.
尽管已证实肺炎球菌疫苗（PCV）的实施对中耳炎（OM）有影响，但由于培养阳性病例较少，缺乏 7 价和 13 价 PCV（PCV7 和 PCV13）的实际血清型特异性有效性的证明。此外，在获得许可前，PCV13 对 OM 的疗效并未得到研究。
该研究于 2009 年 10 月至 2013 年 7 月进行。病例患者为 5-35 月龄患有 OM（主要为复发性/无反应性、自行引流、慢性伴积液）的儿童，从中耳液中获得培养物；对照组为同一年龄组、种族分布和地理位置相似、轮状病毒阴性的肠胃炎前瞻性人群轮状病毒监测的当代儿童。使用无条件逻辑回归估计疫苗效力（VE），将 VE 定义为 1 减去比值比，调整了 PCV 实施后时间、年龄和种族因素。
共研究了 223 例病例患者和 1370 例对照。血清型 19F 和 19A 共同导致所有疫苗型（VT）OM 的 56.1%。5-35 月龄儿童接种≥2 剂 PCV 后，下列疫苗对 OM 的有效性如下：PCV7 对 PCV7 血清型引起的 OM，57.2%（95%置信区间，6.0%-80.5%）；PCV13 对 PCV13 血清型引起的 OM，77.4%（53.3%-92.1%）；PCV13 对 6 种非 PCV7 血清型引起的 OM，67.4%（17.6%-87.1%）；PCV13 对血清型 19F 引起的 OM，91.3%（1.4%-99.2%）；PCV13 对血清型 3 引起的 OM，85.2%（23.9%-98.4%）。PCV7 和 PCV13 对 12-35 月龄儿童血清型 19A 引起的 OM 的 VE 分别为 72.4%（95%置信区间，6.2%-91.9%）和 94.6%（33.9%-99.6%）。
PCV7 和 PCV13 对目标血清型引起的复杂 OM 有效。
