Pfizer Vaccines, Collegeville, PA, USA.
Pfizer Vaccines, Collegeville, PA, USA.
Vaccine. 2019 Sep 10;37(38):5777-5787. doi: 10.1016/j.vaccine.2018.05.097. Epub 2018 May 31.
We conducted a post-hoc analysis of a double blind, randomized, placebo-controlled trial of 13-valent pneumococcal conjugate vaccine (PCV13) among adults aged 65 years or older to assess public health impact.
For all outcomes, we included all randomized subjects, using a modified intention-to-treat (mITT) approach to determine vaccine efficacy (VE), vaccine preventable disease incidence (VPDI) defined as control minus vaccinated group incidence, and numbers needed to vaccinate (NNV) (based on a five-year duration of protection).
Results are reported for, in order, clinical, adjudicated (clinical plus radiologic infiltrate determined by committee), pneumococcal, and vaccine-type pneumococcal (VT-Sp) community-acquired pneumonia; invasive pneumococcal disease (IPD) and VT-IPD. VEs (95% CI) for all hospital episodes were 8.1% (-0.6%, 16.1%), 6.7% (-4.1%, 16.3%), 22.2% (2.0%, 38.3%), 37.5% (14.3%, 54.5%), 49.3% (23.2%, 66.5%), and 75.8% (47.6%, 88.8%). VPDIs per 100,000 person-years of observation (PYOs) were 72, 37, 25, 25, 20, and 15 with NNVs of 277, 535, 816, 798, 1016, and 1342. For clinical CAP, PCV13 was associated with a reduction of 909 (-115, 2013) hospital days per 100,000 PYOs translating to a reduction over 5 years of one hospital day for every 22 people vaccinated. When comparing at-risk persons (defined by self-report of diabetes, chronic lung disease, or other underlying conditions) to not at-risk persons, VEs were similar or lower, but because baseline incidences were higher the VPDIs were approximately 2-10 times higher and NNVs 50-90% lower.
A public health analysis of pneumonia and IPD outcomes in a randomized controlled trial found substantial burden reduction following adult PCV13 immunization implemented in a setting with an ongoing infant PCV7-PCV10 program. VPDIs were higher among at-risk adults.
The original study and the current analysis were funded by Pfizer.
我们对一项针对 13 价肺炎球菌结合疫苗（PCV13）的双盲、随机、安慰剂对照试验进行了事后分析，以评估其对老年人（65 岁及以上）的公共卫生影响。
对于所有结局，我们纳入了所有随机受试者，采用改良意向治疗（mITT）方法来确定疫苗效力（VE）、疫苗可预防疾病发病率（VPDI），即对照组减去接种组的发病率，以及需要接种疫苗的人数（NNV）（基于 5 年的保护期）。
按顺序报告了临床、判定（临床加放射学浸润由委员会确定）、肺炎球菌和疫苗型肺炎球菌（VT-Sp）社区获得性肺炎；侵袭性肺炎球菌病（IPD）和 VT-IPD 的结果。所有住院病例的 VE（95%CI）分别为 8.1%（-0.6%，16.1%）、6.7%（-4.1%，16.3%）、22.2%（2.0%，38.3%）、37.5%（14.3%，54.5%）、49.3%（23.2%，66.5%）和 75.8%（47.6%，88.8%）。每 100,000 人观察年（PYO）的 VPDI 分别为 72、37、25、25、20 和 15，NNV 分别为 277、535、816、798、1016 和 1342。对于临床 CAP，PCV13 可减少 909（-115，2013）个住院天/100,000PYO，相当于每 22 人接种疫苗可减少 1 个住院天。在比较有风险的人（定义为自我报告的糖尿病、慢性肺部疾病或其他潜在疾病）和无风险的人时，VE 相似或更低，但由于基线发病率较高，VPDI 约高 2-10 倍，NNV 低 50-90%。
在一项随机对照试验中，对肺炎和 IPD 结局进行了公共卫生分析，结果发现，在实施婴儿 PCV7-PCV10 计划的同时，对成人进行 PCV13 免疫接种可显著减轻负担。有风险的成年人的 VPDI 更高。
原始研究和当前分析由辉瑞公司资助。
