Data for: Potency testing for a recombinant protein vaccine early in clinical development: lessons from the Schistosoma mansoni Tetraspanin 2 vaccine

Published: 10-06-2021| Version 1 | DOI: 10.17632/3r2bfsjyzz.1
Contributors:
Guangzhao Li,
Lara Hoeweler,
Brian Keegan,
Jin Peng,
Larissa Scholte,
Peter Hotez,
Maria Elena Bottazzi,
David Diemert,
Jeffrey Bethony

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.

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