Thermal stability and epitope integrity of a lyophilized ricin toxin subunit vaccine

Vaccine
Jennifer WestfallNicholas J Mantis

Abstract

Biodefense vaccine are destined to be stockpiled for periods of time and deployed in the event of a public health emergency. In this report, we compared the potency of liquid and lyophilized (thermostabilized) formulations of a candidate ricin toxin subunit vaccine, RiVax, adsorbed to aluminum salts adjuvant, over a 12-month period. The liquid and lyophilized formulations were stored at stressed (40 °C) and unstressed (4 °C) conditions and evaluated at 3, 6 and 12-month time points for potency in a mouse model of lethal dose ricin challenge. At the same time points, the vaccine formulations were interrogated in vitro by competition ELISA for conformational integrity using a panel of three monoclonal antibodies (mAbs), PB10, WECB2, and SyH7, directed against known immunodominant toxin-neutralizing epitopes on RiVax. We found that the liquid vaccine under stress conditions declined precipitously within the first three months, as evidenced by a reduction in in vivo potency and concomitant loss of mAb recognition in vitro. In contrast, the lyophilized RiVax vaccine retained in vivo potency and conformational integrity for up to one year at 4 °C and 40 °C. We discuss the utility of monitoring the integrity of one or more toxin-neutr...Continue Reading

Citations

Feb 19, 2019·Antibodies·Siva Krishna AngalakurthiNicholas J Mantis
Jan 24, 2021·Advanced Drug Delivery Reviews·Kendall B Preston, Theodore W Randolph
Sep 7, 2020·Journal of Immunological Methods·Jennifer DoeringNicholas J Mantis
Mar 17, 2021·Expert Review of Vaccines·Yizhi Qi, Christopher B Fox

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