Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the Schistosoma mansoni Tetraspanin 2 vaccine.

ABSTRACT:

Introduction

As a primary stability-indicating parameter, potency should be strategically evaluated during each phase of vaccine development. Herein, we present potency testing during the early clinical development of the Schistosoma mansoni (Sm) Tetraspanin-2 vaccine formulated on Alhydrogel (Sm-TSP-2/Al). As Sm-TSP-2/Al does not induce sterilizing immunity against its target pathogen (Sm) in animal models, potency is measured by "serological substitution", a method that can add significant variation to the potency metric, especially when used in a compliance (or 'single data point') approach.

Methods

Potency data were analyzed using the compliance approach to determine if two clinical lots of Sm-TSP-2/Al retained pote

SUBMITTER: Li G 

PROVIDER: S-EPMC8209742 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature