Sings Heather L
Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426, USA.
Vaccine. 2017 Sep 25;35(40):5406-5417. doi: 10.1016/j.vaccine.2017.05.075. Epub 2017 Jun 9.
Streptococcus pneumoniae is a frequent cause of community acquired pneumonia (CAP), with the largest burden of disease attributed to non-bacteremic pneumonia. Due to the high persistent burden of disease, pneumococcal pneumonia, particularly non-bacteremic pneumococcal pneumonia, continues to be a major public health concern. There are currently two pneumococcal vaccines approved for use in adults in the United States (US) and other countries worldwide: a 23-valent pneumococcal simple polysaccharide vaccine (PPV23), and a 13-valent pneumococcal conjugate vaccine (PCV13). The capsular polysaccharides included in PPV23 induce antibodies primarily by a T-cell independent mechanism, thus the immune response is short lived and lacks the ability to elicit an anamnestic response. PCV13, on the other hand, has the bacterial polysaccharides covalently conjugated to an immunogenic carrier protein resulting in the formation of memory B lymphocytes, thus proving long-acting immunologic memory and an anamnestic response. Despite 30years of use, the question of PPV23 vaccine efficacy, particularly with respect to efficacy for non-bacteremic pneumonia, has been extensively debated and investigated; whereas PCV13 efficacy against vaccine-type pneumococcal CAP, both bacteremic and non-bacteremic, was confirmed in a large randomized controlled trial in older adults. PCV13 was approved under the US Food and Drug Administration's accelerated pathway, which allows for earlier approval of products that provide meaningful benefit over existing treatments - in this case, protection of adults from non-bacteremic pneumococcal pneumonia. Its use is now increasingly recommended globally. This article summarizes the history and use of PPV23 and PCV13 in adults and how vaccination of adults with PCV13 addresses an unmet medical need.
肺炎链球菌是社区获得性肺炎（CAP）的常见病因，疾病负担主要归因于非菌血症性肺炎。由于疾病负担持续居高不下，肺炎球菌肺炎，尤其是非菌血症性肺炎球菌肺炎，仍然是一个重大的公共卫生问题。目前在美国和世界其他国家，有两种肺炎球菌疫苗被批准用于成人：一种是23价肺炎球菌单纯多糖疫苗（PPV23），另一种是13价肺炎球菌结合疫苗（PCV13）。PPV23中包含的荚膜多糖主要通过T细胞非依赖机制诱导抗体产生，因此免疫反应持续时间短，且缺乏引发回忆反应的能力。另一方面，PCV13将细菌多糖与免疫原性载体蛋白共价结合，从而形成记忆B淋巴细胞，因此具有长效免疫记忆和回忆反应。尽管PPV23已使用了30年，但其疫苗效力问题，尤其是对非菌血症性肺炎的效力问题，一直存在广泛争议并受到研究；而PCV13对疫苗型肺炎球菌CAP（包括菌血症性和非菌血症性）的效力在一项针对老年人的大型随机对照试验中得到了证实。PCV13是根据美国食品药品监督管理局的加速审批途径获批的，该途径允许对那些比现有治疗方法具有显著益处的产品进行更早的审批——在这种情况下，即保护成人免受非菌血症性肺炎球菌肺炎的侵害。目前全球越来越推荐使用PCV13。本文总结了PPV23和PCV13在成人中的应用历史以及使用PCV13对成人进行疫苗接种如何满足了一项未得到满足的医疗需求。
