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Vaccine. 2013 Dec 17;32(1):153-8. doi: 10.1016/j.vaccine.2013.08.061. Epub 2013 Sep 7.

Colonisation endpoints in Streptococcus pneumoniae vaccine trials.

Author information

  • 1Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), P.O. BOX 30, FI-00271, Helsinki, Finland. Electronic address: kari.auranen@thl.fi.
  • 2Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), P.O. BOX 30, FI-00271, Helsinki, Finland.
  • 3University College London Medical School, Institute of Child Health, London, UK.
  • 4Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • 5Pneumococcal Research and Infectious Diseases and Microbiology, Murdoch Childrens Research Institute, Royal Children's Hospital, Parkville, VIC, Australia; Department of Microbiology and Immunology, The University of Melbourne, Parkville, VIC, Australia.

Abstract

Evaluating vaccine efficacy for protection against colonisation (VEcol) with bacterial pathogens is an area of growing interest. In this article, we consider estimation of VEcol for colonisation with Streptococcus pneumoniae (the pneumococcus). Colonisation is a common, recurrent and multi-type endpoint that requires both careful definition of the vaccine efficacy parameter and the corresponding method of estimation. We review recent developments in the area and provide practical guidelines for choosing the estimand and the estimation method in trials with a colonisation endpoint. We concentrate on methods that are based on a cross-sectional study design, in which only one nasopharyngeal sample is obtained per study subject.

Copyright © 2013. Published by Elsevier Ltd.

KEYWORDS:

NVT; Nasopharyngeal colonisation; OR; PCV; Pneumococcus; Trial endpoint; VE(T); VE(acq); VE(col); VT; Vaccine efficacy; combined vaccine efficacy against acquisition and duration of colonisation; non-vaccine (sero)type(s); odds ratio; pneumococcal conjugate vaccine; vaccine (sero)type(s); vaccine efficacy against acquisition of colonisation; vaccine efficacy against colonisation

PMID:
24016803
[PubMed - indexed for MEDLINE]
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