Final pre-clinical testing of a single-injection tetanus vaccine based on biodegradable microspheres in guinea pigs

摘要

One goal of the WHO's Children's Vaccine Initiative was to develop a single-injection vaccine based on biodegradable polymer microspheres (MS) with controlled-release properties. Tetanus toxoid was chosen as a typical antigen, because of its well known in vitro and in vivo properties. A decade later, safety and immunogenic feasibility have not yet been demonstrated in man. One hurdle in this progress was the physicochemical instability of the antigen in such particulate vaccines mostly based on poly(lactide-co-glycolide). However, after several series of independent testing (at NIBSC, Herts., Great Britain) of vaccines from a number of academic and industrial groups, WHO decided to test the most promising formulations in man.