title: Intradermal hepatitis B vaccination in non-responders after topical application of imiquimod (Aldara).
abstract: BACKGROUND
  Five to ten percent of immunocompetent persons fail to develop a protective immune response to hepatitis B vaccination, and are defined non-responders (NR). We investigated the immune response to intradermal hepatitis B vaccination after pre-treatment of the skin with the TLR7 agonist imiquimod.
  
  
  METHODS
  Twenty-one non-responders (anti-HBs <10 IU/l after at least 6 intramuscular hepatitis B vaccinations) were randomly assigned to the control group (N=11) or the experimental group (N=10). Participants in both groups received 3 intradermal (ID) vaccinations with 5 microg HBsAg (0.125 mL) at 0, 1 and 6 months. In the experimental group, the dermal site of injection was pre-treated with 250 mg imiquimod ointment. Anti-HBs antibodies were determined at 0, 1, 2, 6 and 7 months.
  
  
  RESULTS
  In both study groups, 70% of the participants developed a protective immune response (anti-HBs >or=10 IU/l), after the 3rd intradermal vaccination.
  
  
  CONCLUSIONS
  The application of imiquimod on the skin prior to intradermal vaccination did not enhance the humoral response to hepatitis B vaccine. However, irrespective of imiquimod application, 70% of the NR who had not responded to 6 previous intramuscular vaccinations, developed a protective immune response with high affinity antibodies after 3 ID hepatitis B vaccinations with 5 microg HBsAg.
authors.affiliation: Department of Infectious Diseases, Leiden University Medical Center, The Netherlands. a.h.e.roukens@lumc.nl
authors.forename: Anna H
authors.initials: AH
authors.lastname: Roukens
authors.forename: Ann C
authors.initials: AC
authors.lastname: Vossen
authors.forename: Greet J
authors.initials: GJ
authors.lastname: Boland
authors.forename: Willem
authors.initials: W
authors.lastname: Verduyn
authors.forename: Jaap T
authors.initials: JT
authors.lastname: van Dissel
authors.forename: Leo G
authors.initials: LG
authors.lastname: Visser
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage*; D000915:Antibody Affinity; D000917:Antibody Formation; D005260:Female; D006680:HLA Antigens / Q000235:genetics; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000008:administration & dosage / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D000077271:Imiquimod; D056724:Immunity, Humoral; D007117:Immunization, Secondary; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000634:Aminoquinolines; D006680:HLA Antigens; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D000077271:Imiquimod