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In vitro immunogenicity protocol To measure the nave CD4 + T-cell response to TPT and impurities, freshly isolated PBMCs were plated at a density of 2.5 10 5 cells per well in 96-well U-bottom cell plates in RPMI-1640 cell culture media supplemented with IL-2 (10 ng/mL) and IL-7 (20 ng/mL) (Gibco, Grand Island, NY, United States)