biostudies-literatureUnknown8Li GBaylor College of Medicine<h4>Introduction</h4>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 <i>Schistosoma mansoni</i> (<i>Sm</i>) Tetraspanin-2 vaccine formulated on Alhydrogel <i>(Sm</i>-TSP-2/Al). As <i>Sm</i>-TSP-2/Al does not induce sterilizing immunity against its target pathogen (<i>Sm</i>) in animal models, potency is measured by "<i>serological substitution",</i> a method that can add significant variation to the potency metric, especially when used in a compliance (or '<i>single data point'</i>) approach.<h4>Methods</h4>Potency data were analyzed using the compliance approach to determine if two clinical lots of <i>Sm</i>-TSP-2/Al retained poteVaccine: X100100https://www.ebi.ac.uk/biostudies/studies/S-EPMC8209742biostudies-literaturePotency testing for a recombinant protein vaccine early in clinical development: Lessons from the <i>Schistosoma mansoni</i> Tetraspanin 2 vaccine.PMC8209742Li GHoeweler LBottazzi MEKeegan BBethony JScholte LDiemert DPeng JHotez PfalsePotency testing for a recombinant protein vaccine early in clinical development: Lessons from the <i>Schistosoma mansoni</i> Tetraspanin 2 vaccine.<h4>Introduction</h4>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 <i>Schistosoma mansoni</i> (<i>Sm</i>) Tetraspanin-2 vaccine formulated on Alhydrogel <i>(Sm</i>-TSP-2/Al). As <i>Sm</i>-TSP-2/Al does not induce sterilizing immunity against its target pathogen (<i>Sm</i>) in animal models, potency is measured by "<i>serological substitution",</i> a method that can add significant variation to the potency metric, especially when used in a compliance (or '<i>single data point'</i>) approach.<h4>Methods</h4>Potency data were analyzed using the compliance approach to determine if two clinical lots of <i>Sm</i>-TSP-2/Al retained pote2021-01-01T00:00:00Z2021 Aug2026-05-08T00:28:16.806Z2022-02-10T16:28:54.239ZS-EPMC82097423416927010.1016/j.jvacx.2021.100100