13 价肺炎球菌结合疫苗对荷兰随机临床试验中成人疾病结局的公共卫生评估。
A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands.
机构信息
Pfizer Vaccines, Collegeville, PA, USA.
Pfizer Vaccines, Collegeville, PA, USA.
出版信息
Vaccine. 2019 Sep 10;37(38):5777-5787. doi: 10.1016/j.vaccine.2018.05.097. Epub 2018 May 31.
BACKGROUND
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.
METHODS
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
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.
CONCLUSION
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.
FUNDING
The original study and the current analysis were funded by Pfizer.
背景
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。
方法
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）。
结果
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%。
结论
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。
资助
原始研究和当前分析由辉瑞公司资助。
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