Medical Development, Scientific and Clinical Affairs, Pfizer Inc, Collegeville, Pennsylvania, USA.
Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA.
Clin Infect Dis. 2021 Oct 5;73(7):1216-1222. doi: 10.1093/cid/ciab375.
Streptococcus pneumoniae is a causative agent of community-acquired pneumonia (CAP). The 13-valent pneumococcal conjugate vaccine (PCV13) has significantly decreased the burden of PCV13-serotype pneumococcal disease; however, disease from nonvaccine serotypes remains substantial. A recent study documented the persistence of PCV13 serotypes among US adults hospitalized with radiographically confirmed CAP. The current analysis used a recently developed urinary antigen detection (UAD) assay (UAD2) to extend these results to additional serotypes included in an investigational PCV20 vaccine.
This prospective study enrolled adults aged ≥18 years hospitalized with radiographically confirmed CAP between October 2013 and September 2016. Presence of S pneumoniae was determined by blood and respiratory sample culture, BinaxNOW urine testing, and UAD. In addition to Quellung on cultured isolates when available, serotypes were identified from urine specimens using UAD1 for PCV13 serotypes and UAD2 for 7 PCV20-unique serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) and 4 additional serotypes (2, 9N, 17F, and 20).
Among 12 055 subjects with radiographically confirmed CAP, 1482 were positive for S pneumoniae. PCV13- and PCV20-unique serotypes were associated with 37.7% (n = 559) and 27.0% (n = 400) of cases, respectively; 288 subjects were exclusively diagnosed as positive for S pneumoniae by UAD2. Demographic and clinical disease characteristics were similar between subjects with CAP caused by PCV13 and PCV20-unique serotypes.
The current analysis using UAD2 identified a sizeable proportion of hospitalized adult CAP associated with PCV20-unique serotypes. PCV20 may therefore address the burden of CAP caused by the additional serotypes present in the vaccine.
肺炎链球菌是社区获得性肺炎（CAP）的病原体。13 价肺炎球菌结合疫苗（PCV13）显著降低了 PCV13 血清型肺炎球菌疾病的负担；然而，非疫苗血清型的疾病仍然相当严重。最近的一项研究记录了在美国因放射学确诊 CAP 住院的成年人中 PCV13 血清型的持续存在。目前的分析使用了最近开发的尿抗原检测（UAD）检测（UAD2），将这些结果扩展到包含在研究性 20 价肺炎球菌结合疫苗中的其他血清型。
这项前瞻性研究纳入了 2013 年 10 月至 2016 年 9 月期间因放射学确诊 CAP 住院的年龄≥18 岁的成年人。通过血液和呼吸道样本培养、BinaxNOW 尿液检测和 UAD 来确定肺炎链球菌的存在。除了培养分离物时的 Quellung 反应外，还使用 UAD1 检测 PCV13 血清型，使用 UAD2 检测 7 种 PCV20 独特血清型（8、10A、11A、12F、15B、22F 和 33F）和 4 种其他血清型（2、9N、17F 和 20）从尿液标本中确定血清型。
在 12055 名放射学确诊 CAP 患者中，1482 例为肺炎链球菌阳性。PCV13 和 PCV20 独特血清型分别与 37.7%（n=559）和 27.0%（n=400）的病例相关；288 例患者仅通过 UAD2 被诊断为肺炎链球菌阳性。CAP 由 PCV13 和 PCV20 独特血清型引起的患者的人口统计学和临床疾病特征相似。
目前使用 UAD2 的分析确定了相当大比例的与 PCV20 独特血清型相关的住院成人 CAP。因此，PCV20 可能会减轻疫苗中存在的其他血清型引起的 CAP 负担。
