Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.
Rowland R., O'Hara GA., Hamill M., Poulton ID., Donaldson H., Dinsmore L., James T., Barnes E., Klenerman P., Gilbert SC., Hill AVS., Shine B., McShane H.
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.