A post-hoc analysis of serotype-specific vaccine efficacy of 13-valent pneumococcal conjugate vaccine against clinical community acquired pneumonia from a randomized clinical trial in the Netherlands.


Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
09 07 2019
Historique:
received: 11 12 2018
revised: 22 05 2019
accepted: 23 05 2019
pubmed: 4 6 2019
medline: 8 9 2020
entrez: 4 6 2019
Statut: ppublish

Résumé

Serotype-specific vaccine efficacy (VE) against adult community acquired pneumonia (CAP) remains poorly defined, yet such data are important for assessing the utility of adult pneumococcal conjugate vaccine (PCV) programs. We evaluated the Community Acquired Pneumonia Immunization Trial in Adults to assess serotype-specific VE for CAP. This parallel-arm randomized clinical trial assessed 13-valent PCV (PCV13) VE among community dwelling persons aged ≥65 years in The Netherlands. In the original analysis, PCV13 VE against first episodes of vaccine-type (VT) chest radiology confirmed CAP was 45.6% (95% confidence interval [CI] 21.8-62.5%). Unlike the original analysis, we included any subject that met a clinical definition of CAP regardless of radiographic findings. VT-CAP was identified by culture (sterile or non-sterile) or serotype-specific urinary antigen detection (SSUAD) test. Only the five serotypes with at least 10 episodes in the control arm, based on the original analysis, were included for VE assessment. Of 272 clinical CAP visits with VT serotypes identified, 253 (93%) were identified by SSUAD including 210 (77%) by SSUAD alone. VE was determined for serotypes 1, 3, 6A, 7F, and 19A, with total first episodes of, respectively, 27, 36, 25, 38, and 48. VE (95%CI) for the five evaluated serotypes against first clinical CAP episodes were: serotype 1, 20.0% (-83.1% to 65.8%); serotype 3, 61.5% (17.6-83.4%); serotype 6A, 33.3% (-58.6% to 73.2%); serotype 7F, 73.3% (40.5-89.4%); and serotype 19A, 45.2% (-2.2% to 71.5%). Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults. The VE point estimates and CIs for serotypes 1, 6A, and 19A were lower but consistent with the overall VT-CAP VE of 45.6% previously reported. These findings may be relevant in models to accurately account for the potential impact of adult PCV13 immunization.

Sections du résumé

BACKGROUND
Serotype-specific vaccine efficacy (VE) against adult community acquired pneumonia (CAP) remains poorly defined, yet such data are important for assessing the utility of adult pneumococcal conjugate vaccine (PCV) programs.
METHODS
We evaluated the Community Acquired Pneumonia Immunization Trial in Adults to assess serotype-specific VE for CAP. This parallel-arm randomized clinical trial assessed 13-valent PCV (PCV13) VE among community dwelling persons aged ≥65 years in The Netherlands. In the original analysis, PCV13 VE against first episodes of vaccine-type (VT) chest radiology confirmed CAP was 45.6% (95% confidence interval [CI] 21.8-62.5%). Unlike the original analysis, we included any subject that met a clinical definition of CAP regardless of radiographic findings. VT-CAP was identified by culture (sterile or non-sterile) or serotype-specific urinary antigen detection (SSUAD) test. Only the five serotypes with at least 10 episodes in the control arm, based on the original analysis, were included for VE assessment.
RESULTS
Of 272 clinical CAP visits with VT serotypes identified, 253 (93%) were identified by SSUAD including 210 (77%) by SSUAD alone. VE was determined for serotypes 1, 3, 6A, 7F, and 19A, with total first episodes of, respectively, 27, 36, 25, 38, and 48. VE (95%CI) for the five evaluated serotypes against first clinical CAP episodes were: serotype 1, 20.0% (-83.1% to 65.8%); serotype 3, 61.5% (17.6-83.4%); serotype 6A, 33.3% (-58.6% to 73.2%); serotype 7F, 73.3% (40.5-89.4%); and serotype 19A, 45.2% (-2.2% to 71.5%).
DISCUSSION
Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults. The VE point estimates and CIs for serotypes 1, 6A, and 19A were lower but consistent with the overall VT-CAP VE of 45.6% previously reported. These findings may be relevant in models to accurately account for the potential impact of adult PCV13 immunization.

Identifiants

pubmed: 31155413
pii: S0264-410X(19)30702-9
doi: 10.1016/j.vaccine.2019.05.065
pii:
doi:

Substances chimiques

13-valent pneumococcal vaccine 0
Pneumococcal Vaccines 0
Vaccines, Conjugate 0

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

4147-4154

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Bradford D Gessner (BD)

Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@Pfizer.com.

Qin Jiang (Q)

Pfizer Vaccines, Collegeville, PA, USA.

Cornelis H Van Werkhoven (CH)

Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands.

Heather L Sings (HL)

Pfizer Vaccines, Collegeville, PA, USA.

Chris Webber (C)

Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.

Daniel Scott (D)

Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.

William C Gruber (WC)

Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.

Diederick E Grobbee (DE)

Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Julius Clinical, Academic Contract Research Organization, Zeist, the Netherlands.

Marc J M Bonten (MJM)

Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.

Luis Jodar (L)

Pfizer Vaccines, Collegeville, PA, USA.

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