[摘要]: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 IpxL1. Bioneedles with HBsAg-IpxL1 were the most stable and the most immunogenic formulations. The conventional liquid alum adjuvated vaccine lost 40% of its antigenicity after 1 week at 50 degrees C whereas the HBsAg-IpxL1 Bioneedles showed no significant decrease after 3 weeks at 50 degrees C. in vivo studies revealed that the HBsAg-IpxL1 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. (C) 2010 Elsevier B.V. All rights reserved.