Michael W. Pride, United States of America

Pfizer Inc. Vaccines Clinical Research and Development

Author Of 2 Presentations

LARGER BENEFIT OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV13) ON VACCINE PREVENTABLE DISEASE IN ADULTS (ID 625)

Abstract

Background

In the Netherlands randomized controlled trial (RCT) of 13-valent pneumococcal conjugate vaccine (PCV13) among persons age 65+ years, the primary outcome was chest x-ray (CXR) confirmed, vaccine-type (VT) primarily non-bacteremic Community Acquired Pneumonia (CAP), the latter determined almost entirely by serotype-specific urinary antigen detection (SSUAD). The sensitivity and specificity of SSUAD and CXR for identifying primarily non-bacteremic pneumonia preventable by PCV13 is unknown.

Methods

In the Netherlands RCT, we compared vaccine-preventable-disease-incidence (VPDI) for all episodes of clinically defined CAP to that for CXR-confirmed VT-CAP. VPDI was calculated as the incidence rate difference between controls and vaccinated persons.

Results

VPDI per 100,000 person-years of follow-up for all episodes of clinical CAP vs. VT-CAP were: total population, 72.2/25.1 (2.9-fold); at-risk condition for pneumococcus other than immunosuppression, 121.4/34.3 (3.5-fold); and not at-risk, 35.5/17.6 (2.0-fold) (Table).

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Conclusions

PCV13 prevented 2.0 to 3.5 more episodes of clinical CAP than CXR-confirmed VT-CAP, reflecting that SSUAD was designed for the regulatory outcome of vaccine efficacy, which relies on test specificity, and that CXR may have imperfect sensitivity for CAP in elderly persons. Assessing PCV13’s true public health value will require use of rate reductions or adjustment factors to account for clinically defined CAP.

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STREPTOCOCCUS PNEUMONIAE SEROTYPE DISTRIBUTION AND COVERAGE OF PNEUMOCOCCAL CONJUGATE VACCINES IN ADULTS HOSPITALIZED WITH COMMUNITY-ACQUIRED PNEUMONIA IN THE UNITED STATES (ID 879)

Abstract

Background

The study objective was to determine the prevalence of serotypes and coverage provided by currently licensed and next generation pneumococcal conjugate vaccines (PCVs) in adults hospitalized with community-acquired pneumonia (CAP) in the United States.

Methods

Hospitalized adults aged ≥18 years with radiologically-confirmed (CXR+) CAP were enrolled from 10 U.S. cities between October 2013 and September 2016. S. pneumoniae isolates cultured from normally-sterile standard-of-care specimens were serotyped by Quellung. Urine was tested using BinaxNOW® and a serotype-specific urine antigen detection (UAD) assay that detects serotypes contained in PCV13 plus 6C (highly-related to 6A), PCV15 (PCV13 serotypes, 22F, and 33F), PCV20 (PCV15 serotypes, 8, 10A, 11A, 12F, and 15B plus 15C (highly-related to 15B)), and non-PCV serotypes 2, 9N, 17F, and 20. Coverage was calculated as the percent of CXR+CAP participants positive for a serotype in PCV13, PCV15, and PCV20.

Results

Of 15,572 enrolled participants, 12,055 with CXR+CAP were included in the analysis; 52.7% (n=6347) were ≥65 years. Coverage of CXR+CAP varied by PCV formulation (Table). About 1% of CXR+CAP was due to serotypes 2, 9N, 17F, and 20 combined.

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Conclusions

Compared to PCV13, PCV20 increased coverage of CXR+CAP due to PCV serotypes by 71% (18-64 years) and 64% (≥65 years).

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