A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands
Gessner, Bradford D; Jiang, Qin; Van Werkhoven, Cornelis H; Sings, Heather L; Webber, Chris; Scott, Daniel; Neuzil, Kathleen M; O'Brien, Katherine L; Wunderink, Richard G; Grobbee, Diederick E; Bonten, Marc J M; Jodar, Luis
(2019) Vaccine, volume 37, issue 38, pp. 5777 - 5787
(Article)
Abstract
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),
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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.
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Keywords: General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases, Molecular Medicine, General Immunology and Microbiology
ISSN: 0264-410X
Publisher: Elsevier BV
Note: Funding Information: BDG, QJ, HLS, CW, DS, and LJ are employees of Pfizer Inc. KLOB reports research grant funding for pneumococcal vaccines from Pfizer, GSK, Gavi the Vaccine Alliance, the Bill & Melinda Gates Foundation, and the US National Institutes of Health and has served on pneumococcal advisory groups for Merck, Sanofi Pasteur, Affinivax, ClearPath, and PATH. RGW participates in a clinical evaluation committee for a Pfizer-sponsored antibiotic trial. MJMB reports research grant funding for vaccine related studies from Pfizer, Arsanis, Johnson and Johnson and Janssen Vaccines and advisory board and speaker fees from Pfizer and Janssen Vaccines. The remaining authors report no conflicts of interest. Funding Information: This study was sponsored by Pfizer Inc. The sponsor was involved with study concept and design, conduct, analysis and interpretation of the data, drafting of the manuscript, and the decision to submit the manuscript for publication. The corresponding author had full access to the study data and had final responsibility for the decision to submit for publication. Publisher Copyright: © 2018 The Author(s)
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