Bioneedles as alternative delivery system for hepatitis B vaccine.

An alternative vaccine delivery system for needle injections is the Bioneedle. Hepatitis B surface antigen (HBsAg) was formulated with Bioneedles. Three formulations were used: plain antigen, HBsAg adjuvated with aluminum hydroxide and HBsAg with LPS-derived lpxL1. Bioneedles with HBsAg-lpxL1 were the most stable and the most immunogenic formulations. The conventional liquid alum adjuvated vaccine lost 40% of its antigenicity after 1week at 50°C whereas the HBsAg-lpxL1 Bioneedles showed no significant decrease after 3 weeks at 50°C. In vivo studies revealed that the HBsAg-lpxL1 Bioneedle formulations induced comparable IgG titers as conventional liquid formulations after 2 immunizations, but higher IgG2a titers were found already after 1 immunization. The in vivo and in vitro studies showed that the Bioneedle is an attractive alternative for needle injections of HBsAg vaccines.