Statistical Methods for MIMIC Assay Data

• Activity Number: 372
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Robert D. Small*
• Companies: Sanofi Pasteur
• Keywords: Vaccine ; Immuno assay

Abstract

The MIMIC assay system is an in-vitro assay that allows vaccines to be tested on sera or whole blood from human donors. Since the tests on the donor blood is done external to the donor there are numerous advantages including the ability to test different vaccines on the same donor. This allows by passing the memory of the innate and adaptive features of the human immune system. We will discuss the advantages of these designs over other vaccine designs and exploit certain kinds of correlations to reduce variance and to estimate the variability of human immune system to particular vaccines. As an example we show how the assay can be used on non-inferiority comparisons of vaccines.