title: Bioneedles as alternative delivery system for hepatitis B vaccine.
abstract: 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.
authors.affiliation: Unit R&D, Netherlands Vaccine Institute, Bilthoven, The Netherlands. hoang.hirschberg@nvi-vaccin.nl
authors.forename: Hoang J H B
authors.initials: HJ
authors.lastname: Hirschberg
authors.forename: Gijsbert G P
authors.initials: GG
authors.lastname: van de Wijdeven
authors.forename: Heleen
authors.initials: H
authors.lastname: Kraan
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Amorij
authors.forename: Gideon F A
authors.initials: GF
authors.lastname: Kersten
mesh_terms: D020341:Absorbable Implants; D000276:Adjuvants, Immunologic; D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry; D002942:Circular Dichroism; D004339:Drug Compounding; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D005612:Freeze Drying; D006511:Hepatitis B Antigens / Q000008:administration & dosage / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D051379:Mice; D008807:Mice, Inbred BALB C
chemical_list: D000276:Adjuvants, Immunologic; D001672:Biocompatible Materials; D006511:Hepatitis B Antigens; D017325:Hepatitis B Vaccines; D007074:Immunoglobulin G; D007075:Immunoglobulin M