Progress in biological threat agent vaccine development: a repeat-dose toxicity study of a recombinant ricin toxin A-chain (rRTA) 1-33/44-198 vaccine (RVEc) in male and female New Zealand white rabbits.

A recombinant ricin toxin A-chain 1-33/44-198 vaccine (RVEc) was administered to male and female New Zealand white (NZW) rabbits (10/sex/group) in a repeat-dose toxicity study. The RVEc vaccine was administered on study days 1, 29, 57, and 85 via intramuscular (IM) injection (0, 100, or 200 μg/dose). All study animals were observed throughout treatment until euthanized and submitted for necropsy on study day 88 or 99 (recovery period). There were no treatment-related or toxicologically significant effects observed. There were no statistically significant differences noted in the antibody titers and/or concentrations in 100 μg RVEc-treated animals when compared to 200 μg RVEc-treated animals, suggesting that both doses produced comparable antibody titers/concentrations during the study. The highest immune response was observed on study day 99 (ie, 2 weeks after the last dose). The immune response observed demonstrated that RVEc is biologically active in the rabbit model, with no apparent marked sex differences.