VACCINE-PREVENTABLE CLINICAL VERSUS RADIOLOGICALLY- OR ETIOLOGICALLY-CONFIRMED DISEASE IN PNEUMOCOCCAL CONJUGATE VACCINE EFFICACY TRIALS: A SYSTEMATIC LITERATURE REVIEW AND RE-ANALYSIS (ID 762)

Session Name
Clinical Sciences - Diagnosis
Presenter
  • Bradford D. Gessner, United States of America
Authors
  • Kaatje E. Bollaerts, Belgium
  • Mark Fletcher, United States of America
  • Jose A. Suaya, United States of America
  • Germaine Hanquet, Belgium
  • Marc Baay, Belgium
  • Lindsay R. Grant, United States of America
  • Christian Theilacker, Germany
  • Thomas Verstraeten, Belgium
  • Bradford D. Gessner, United States of America

Abstract

Background

While regulatory endpoints for pneumococcal conjugate vaccines (PCVs) routinely include radiologically- or vaccine serotype (VST) confirmed disease, public health decision-making benefits from consideration of all disease prevented regardless of diagnostic or etiological confirmation.

Methods

We followed PRISMA guidelines to perform a systematic literature review for Phase III/IV efficacy trials of PCVs from 1997 through 2019. We estimated study-specific vaccine-preventable disease incidence (VPDI) (control group minus intervention group incidences) for all-cause disease versus radiologically- and/or etiologically-confirmed outcomes. VPDI ratios between the broadest clinical and most narrowly defined outcomes were calculated [PROSPERO registration, CRD42019145268].

Results

Ten studies met the criteria. In children < 5 years, VPDI ratios ranged from 0.6 to 3.7 for otitis media (clinical versus VST etiologically-confirmed); from 1.3 to 1.8 for pneumonia (clinical versus radiologically-confirmed); 3.1 and 19.0 for pneumonia (clinical versus bacterial or VST); and 3.8 in one study of invasive pneumococcal disease (non-laboratory to laboratory-confirmed). In adults, VPDI ratios ranged from 2.2 to 2.9 for pneumonia (clinical to pneumococcal or VST).

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Conclusions

Relying on only radiologically-confirmed or etiologically-confirmed outcomes substantially underestimated PCVs’ public health benefits. Broader clinical outcomes should be considered by vaccine technical committees when making decisions for pediatric and adult PCV use.

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