Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines

Rosalind Rowland, Geraldine A. O'Hara, Matthew Hamill, Ian D. Poulton, Hannah Donaldson, Laura Dinsmore, Timothy James, Eleanor Barnes, Paul Klenerman, Sarah C. Gilbert, Adrian V.S. Hill, Brian Shine, Helen McShane

Research output: Contribution to journalArticlepeer-review

Abstract

This was a retrospective study to determine the validity of institutional reference intervals for interpreting biochemistry and hematology results in healthy adults in the context of clinical trials of preventive vaccines. An example population of 974 healthy adults participating in clinical trials at the Jenner Institute, Oxford, UK, between 1999 and 2009 was studied. Methods for calculating the central 95% ranges and determining the coefficients of within person variation were demonstrated. Recommendations have been made as to how these data can be usefully applied to the interpretation of blood results in healthy adult subjects for the purposes of clinical trial inclusion decisions and post-vaccination safety monitoring.

Original languageEnglish (US)
Pages (from-to)1741-1751
Number of pages11
JournalHuman Vaccines and Immunotherapeutics
Volume9
Issue number8
DOIs
StatePublished - Aug 2013
Externally publishedYes

Keywords

  • Candidate vaccines
  • Clinical trials
  • Haematological and biochemical reference intervals
  • Healthy young adult subjects
  • Preand post-intervention safety analysis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

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