Raul Isturiz, United States of America

Pfizer Inc Medical Development Scientific and Clinical Affairs

Author Of 12 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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EARLY AND LATE MORTALITY OF ADULTS HOSPITALIZED WITH PNEUMOCOCCAL PNEUMONIA IN THE UNITED STATES (ID 797)

Abstract

Background

The number of deaths due to pneumococcal pneumonia (PP) in the United States (U.S.) is not well defined. The objectives of this study were to define mortality of PP in the city of Louisville, Kentucky and to estimate the number of deaths in hospitalized patients with PP in the U.S.

Methods

In hospitalized patients with community-acquired pneumonia (CAP), urinary antigen detection of 24 S. pneumoniae serotypes (UAD-24) was performed. This UAD-24 study was nested in a prospective population-based cohort study of all adult residents in Louisville, hospitalized with CAP from 6/1/14 to 5/31/16. Louisville PP mortality was evaluated early (during hospitalization and at 30-days after hospitalization) and late (6-months and 1-year after hospitalization) and US number of deaths were estimated.

Results

A total of 708 patients with PP were evaluated. PP mortality was 3.7% during hospitalization, 8.2% at 30-days, 17.6% at 6-months, and 25.4% at 1-year. Number of deaths in the U.S. were: 8,323 (95%CI:5,468-12,091) during hospitalization, 18,619 (95%CI:14,231-23,711) at 30-days, 39,807 (95%CI:33,506-46,502) at 6 months, and 57,626 (95%CI:50,130-64,940) at 1-year.

Conclusions

In hospitalized patients, PP is associated with significant early and late mortality. Approximately 1 out of 4 hospitalized adult patients with PP will die within 1-year.

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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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COMMUNITY ONSET PNEUMONIA INCIDENCE IN ADULTS 18 YEARS AND OLDER IN GOTO ISLAND, JAPAN. INTERIM RESULTS FROM A POPULATION BASED PROSPECTIVE STUDY (ID 596)

SEROTYPE AND ANTIMICROBIAL CHARACTERISTICS OF STREPTOCOCCUS PNEUMONIAE ISOLATES OBTAINED FROM JAPANESE ADULT PATIENTS WITH COMMUNITY ONSET PNEUMONIA (COP) IN GOTO ISLAND, JAPAN (ID 611)