Modeling adaptive response profiles in a vaccine clinical trial.

BMC Medical Research Methodology
Dicle HasdemirAge K Smilde

Abstract

Vaccine clinical studies typically provide time-resolved data on adaptive response read-outs in response to the administration of that particular vaccine to a cohort of individuals. However, modeling such data is challenged by the properties of these time-resolved profiles such as non-linearity, scarcity of measurement points, scheduling of the vaccine at multiple time points. Linear Mixed Models (LMM) are often used for the analysis of longitudinal data but their use in these time-resolved immunological data is not common yet. Apart from the modeling challenges mentioned earlier, selection of the optimal model by using information-criterion-based measures is far from being straight-forward. The aim of this study is to provide guidelines for the application and selection of LMMs that deal with the challenging characteristics of the typical data sets in the field of vaccine clinical studies. We used antibody measurements in response to Hepatitis-B vaccine with five different adjuvant formulations for demonstration purposes. We built piecewise-linear, piecewise-quadratic and cubic models with transformations of the axes with pre-selected or optimized knot locations where time is a numerical variable. We also investigated models w...Continue Reading

References

Aug 1, 1994·Journal of Hepatology·P CoursagetI Diop-Mar
Jan 24, 2007·Cognitive Psychology·Christoph ScheepersMirella Lapata
Dec 9, 2008·Journal of Memory and Language·Daniel MirmanJames S Magnuson
Feb 3, 2009·Trends in Ecology & Evolution·Benjamin M BolkerJada-Simone S White
May 29, 2016·Clinical Immunology : the Official Journal of the Clinical Immunology Society·Geert Leroux-RoelsMarcelle Van Mechelen

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Software Mentioned

lme4
Cubic
R
cAIC4

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