Data for: Potency testing for a recombinant protein vaccine early in clinical development: lessons from the Schistosoma mansoni Tetraspanin 2 vaccine
Description
This dataset contains the potency data used for analysis in the paper “Potency testing for a recombinant protein vaccine early in clinical development: lessons from the Schistosoma mansoni Tetraspanin 2 vaccine” published in Vaccine X. Variable names and descriptions Lot #: The two manufactured lots (Aeras Lot# 11-69f-003 and WRAIR Lot #1975) of the recombinant Schistosoma mansoni (Sm) Tetraspanin-2 vaccine formulated on Alhydrogel (Sm-TSP-2/Al). Months Post-release: Potency timepoint in months post-release (0 = at release). Dose in μg: Immunization dose of Sm-TSP-2. Optical Density (OD): Optical Density measured at 492nm by indirect ELISA in serum samples diluted at 1:6000. Arbitrary Units (AU): Anti-Sm-TSP-2 IgG levels reported in Arbitrary Units (AU) determined from interpolating OD492nm for each sample onto a Global Standard Calibration Curve (GSCC). Reactivity Threshold (RT) in AU: The concentration of antibody expressed in AUs of IgG against Sm-TSP-2/Al, corresponding to the interpolated intersection of the lower asymptote of the upper 95% confidence limit with the lower 95% confidence limit of the GSCC. Limit of Quantification (LOQ) in AU: The concentration of antibody expressed in AUs of IgG against Sm-TSP-2/Al, corresponding to the interpolated intersection of the lower asymptote of the upper 95% confidence limit with the GSCC. Seropositivity: Whether the mouse seroconverted post-prime immunization (0= negative; 1= positive); Mice were considered seroconverted, or "responders", if the AU was above RT.