A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands

Bradford D. Gessner*, Qin Jiang, Cornelis H. Van Werkhoven, Heather L. Sings, Chris Webber, Daniel Scott, Kathleen M. Neuzil, Katherine L. O'Brien, Richard G Wunderink, Diederick E. Grobbee, Marc J.M. Bonten, Luis Jodar

*Corresponding author for this work

Research output: Contribution to journalArticle

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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), 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.

Original languageEnglish (US)
JournalVaccine
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Conjugate Vaccines
randomized clinical trials
Netherlands
public health
Randomized Controlled Trials
Public Health
vaccines
Incidence
Vaccines
pneumonia
Observation
Pneumococcal Pneumonia
Pneumococcal Vaccines
incidence
Self Report
Lung Diseases
Immunization
Pneumonia
Chronic Disease
funding

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

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. / A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands. In: Vaccine. 2018.
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title = "A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands",
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), 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.",
author = "Gessner, {Bradford D.} and Qin Jiang and {Van Werkhoven}, {Cornelis H.} and Sings, {Heather L.} and Chris Webber and Daniel Scott and Neuzil, {Kathleen M.} and O'Brien, {Katherine L.} and Wunderink, {Richard G} and Grobbee, {Diederick E.} and Bonten, {Marc J.M.} and Luis Jodar",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.vaccine.2018.05.097",
language = "English (US)",
journal = "Vaccine",
issn = "0264-410X",
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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.

In: Vaccine, 01.01.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands

AU - Gessner, Bradford D.

AU - Jiang, Qin

AU - Van Werkhoven, Cornelis H.

AU - Sings, Heather L.

AU - Webber, Chris

AU - Scott, Daniel

AU - Neuzil, Kathleen M.

AU - O'Brien, Katherine L.

AU - Wunderink, Richard G

AU - Grobbee, Diederick E.

AU - Bonten, Marc J.M.

AU - Jodar, Luis

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

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