Immunogenicity of a newly developed vaccine against

Background and Aim: Materials and Methods: The vaccine was formulated of its constituents for 1 h. Each milliliter of the final vaccine product contained alpha toxoid 15 lecithovitellinase activity (Lv) by adding (0.375 mL containing 40 Lv) and approximately 0.2 mL from 3% concentrated aluminum hydroxide gel, <0.001% W/V thiomersal, <0.05% W/V formaldehyde, and nearly 0.425 mL phosphate-buffered saline (pH 7.2). The vaccine efficacy was evaluated in rabbits and cattle by performing potency, stability, and safety tests. Results: The vaccine produced approximately 8.8 and 4.9 IU/mL neutralizing antibodies in rabbits and cattle, respectively. These concentrations were higher than the lowest concentration recommended by various international protocols and the United States Department of Agriculture by 2.20-fold in rabbits and 1.23-fold in cattle. Interestingly, the formulated vaccine enhanced immune responses by 1.80-fold in rabbits compared with that in cattle; the difference was statistically significant (p < 0.0001). The vaccine was stable for 30 months. In vaccinated rabbits, the body temperature slightly increased temporarily during the first 10 h of vaccination; however, the temperature difference was not statistically significant (p > 0.05). Conclusion: This study describes a manufacturing process to obtain sufficient amounts of a vaccine against