{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8"],"submitter":["Li G"],"funding":["Baylor College of Medicine"],"pubmed_abstract":["<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 pote"],"journal":["Vaccine: X"],"pagination":["100100"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8209742"],"repository":["biostudies-literature"],"pubmed_title":["Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the <i>Schistosoma mansoni</i> Tetraspanin 2 vaccine."],"pmcid":["PMC8209742"],"pubmed_authors":["Li G","Hoeweler L","Bottazzi ME","Keegan B","Bethony J","Scholte L","Diemert D","Peng J","Hotez P"],"additional_accession":[]},"is_claimable":false,"name":"Potency testing for a recombinant protein vaccine early in clinical development: Lessons from the <i>Schistosoma mansoni</i> Tetraspanin 2 vaccine.","description":"<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 pote","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Aug","modification":"2026-05-08T00:28:16.806Z","creation":"2022-02-10T16:28:54.239Z"},"accession":"S-EPMC8209742","cross_references":{"pubmed":["34169270"],"doi":["10.1016/j.jvacx.2021.100100"]}}