Hand-in-hand work between the Sponsor and the BA lab : a 5-year journey feedback toward the successful use of an IFN-γ ELISpot method supporting the clinical development of a new vaccine candidate
Developing reliable methods for monitoring cellular responses to a vaccine is akin to an obstacle course all along the process, from bedside - drawing blood from the patient - to bench - analyzing these samples for their immunogenicity. Understanding the context of use of the assay, including indication, expected magnitude of responses, injection regimen (prime +/- boost), sampling schedule, end use of data (dose-finding, correlates of protection, surrogate marker, statistical analysis…) determine the design and the level of validation of the assay.
We illustrate here how, during the clinical development of OVX836, an innovative universal flu vaccine candidate, Osivax, as the Sponsor, and Active Biomarkers, as the bioanalytical lab, have worked hand-in-hand to develop an IFN-g ELISpot method and improve its robustness throughout the clinical development of the vaccine. We will showcase the steps allowing to move forward from an exploratory endpoint in phase 1 – which aims at exploring the kinetics of responses to the vaccine in relation with the route of administration and the dose of the vaccine – to a primary endpoint in more advanced phase 2 clinical studies. We show how sample integrity, strict control of the critical reagents, and of the method along clinical sample analysis are the key elements that will determine the reliability and comparability of data across clinical studies.