Three Competitive ELISAs to Quantify the D-Antigen Content of Aluminum-Salt Adjuvanted Recombinant Polio VLPs (Types 1, 2, 3) to Enable Preformulation Characterization Studies (Dataset)
Liu, Yanli Dotson, Brandy Joshi, Sangeeta B.
Liu, Yanli
Dotson, Brandy
Joshi, Sangeeta B.
Abstract
Recombinant poliovirus (PV) virus-like particle (VLP) antigens mimic the conformation of the surface proteins in native PVs (i.e., serotype-specific D-antigen epitopes). Since they lack genomes and are non-infectious, PV-VLPs offer the promise of a safer, next-generation polio vaccine compared to traditional inactivated (IPV) or attenuated, live (OPV) vaccines. Sandwich D-antigen ELISA formats are commonly-used to measure the in vitro potency values (relative D-antigen content, DU/mL) of unadjuvanted trivalent IPV antigens. If IPV is formulated with aluminum-salt adjuvants, however, a pretreatment step (i.e., adjuvant dissolution or antigen desorption) is required which may compromise antigen integrity during sample handling. This work describes development of three competitive ELISAs to measure the relative D-antigen content of aluminum-salt adjuvanted PV-VLPs (Types 1, 2, 3) without the need for pretreatment. First, key assay parameters were established including specificity, accuracy, precision, linearity, limit of quantification, and stability-indication. Next, preformulation characterization studies were performed with these methods including (1) rank-ordering the inherent thermal stability profiles of the PV-VLPs (Types 1 > 3 > 2) in-solution and adsorbed to an aluminum phosphate adjuvant (AdjuPhos™, AP) and (2) determining the effect of formulation variables on the thermal stability profiles of AP-adsorbed PV-VLPs including antimicrobial preservatives (thimerosal, 2-PE) and five different antigens present in pediatric combination vaccines (D, T, wP, Hib, Hep B). The application of these competitive D-antigen ELISAs to future formulation and storage stability studies with the AP-adjuvanted, trivalent PV-VLPs (Types 1, 2, 3) is discussed with the goal to develop a stable, efficacious multi-dose, hexavalent combination vaccine presentation.
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Date
2026-02-27
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Keywords
Vaccine, Stability, Formulation, Adjuvant, Preservatives, Adju-Phos, Poliovirus, Virus-Like Particles, ELISA, Potency, D-antigen