Persistence clinical studies

Abstract

Long-term immunity, evaluated by the persistence of antibody titers, is important to assess duration of protection induced by vaccination. This paper aims at drawing awareness on the risk of misinterpreting persistence results in absence of adjustment for missing or left-censored data. Using simulations, the paper shows that repeated measurement models are an appropriate alternative to control the bias associated to unadjusted persistence results.

Keywords: :

• persistence
• missing data
• repeated measurement
• left-censored data
• long-term antibody

Authors Contributions

B.C. led the project of simulations and has coordinated the paper writing. Other authors have contributed to the simulations, case study analysis and paper writing. All authors have critically reviewed the draft manuscript at various stages and have approved the final version of the manuscript.

Conflict of Interest

All authors are employed by the GlaxoSmithKline group of companies.

Role of funding source

GlaxoSmithKline Biologicals SA took in charge all costs associated with the development and publication of this manuscript.