title: Induction of a robust T- and B-cell immune response in non- and low-responders to conventional vaccination against hepatitis B by using a third generation PreS/S vaccine.
abstract: Non-responsiveness to conventional hepatitis B vaccines in individuals at high risk of exposure to hepatitis B virus (HBV) is an important public health problem and of particular relevance in health care providers. Yeast-derived conventional HBsAg vaccines fail to induce protective antibody titers in up to 10% of immune competent vaccinees. Therefore, a third generation HBV vaccine, Sci-B-Vac™, was developed which contains in addition to the small S antigen the PreS1 and PreS2 antigens. This vaccine proved to induce a highly potent cellular and humoral immune response in healthy individuals as well as protective antibody levels in non- and low-responders to conventional HBV vaccines. The aim of the study was to examine whether Sci-B-Vac™ triggers cellular and humoral immunity in individuals who failed immunization with conventional vaccines. We immunized 21 volunteers (15 non- and 6 low-responders) according to the standard vaccination schedule (0, 4 and 24 weeks), determined the cellular immunity by proliferation assay and interferon (IFN)-γ ELISpot and measured the anti-HBs antibody titers prior to each vaccination and four weeks after the third vaccine dose. Following three vaccinations, PreS/S-specific T-cell proliferation was detected in 8 out of 15 non-responders and 5 out of 6 low-responders. Specific IFN-γ responses were measured in 2 out of 15 non-responders and 4 out of 6 low-responders. All but one (20/21) study participants developed anti-HBs titers ≥10IU/l after three vaccinations. Anti-HBs ≥100IU/L were detected in 12 out of 15 non-responders and in 6 out of 6 low-responders. Anti-HBs ≥10IU/l and <100IU/l were found in 2 non-responders. These results indicate that Sci-B-Vac™ induces cellular immunity as well as protective anti-HBs antibody titers in non- and low-responders. In conclusion, these results confirm that Sci-B-Vac™ should be administered to non-responders to conventional HBV vaccines and patients with impaired immune function.
authors: Institute of Virology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany. Electronic address: Adalbert.Krawczyk@uni-due.de.
authors: Adalbert
authors: A
authors: Krawczyk
authors: Institute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstraße 55, 45147 Essen, Germany. Electronic address: Charotte.Ludwig@stud.uni-due.de.
authors: Charlotte
authors: C
authors: Ludwig
authors: Department of Gastroenterology and Hepatology, University Hospital Essen, University of Duisburg-Essen, Hufelandstraße 55, 45147 Essen, Germany. Electronic address: Christoph.Jochum@uk-essen.de.
authors: Christoph
authors: C
authors: Jochum
authors: Institute of Virology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany. Electronic address: Melanie.Fiedler@uni-due.de.
authors: Melanie
authors: M
authors: Fiedler
authors: Institute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstraße 55, 45147 Essen, Germany. Electronic address: Falko.Heinemann@uk-essen.de.
authors: Falko M
authors: FM
authors: Heinemann
authors: Hadassah Medical Center, Liver Unit, POB 12000, Jerusalem 91120, Israel. Electronic address: Shouval@hadassah.org.il.
authors: Daniel
authors: D
authors: Shouval
authors: Institute of Virology, University Hospital Essen, University of Duisburg-Essen, Hufelandstrasse 55, 45147 Essen, Germany. Electronic address: Michael.Roggendorf@uni-due.de.
authors: Michael
authors: M
authors: Roggendorf
authors: Institute of Molecular Immunology, University Hospital TUM, Schneckenburgerstr. 8, 81675 München, Germany. Electronic address: Hedwig.Roggendorf@tum.de.
authors: Hedwig
authors: H
authors: Roggendorf
authors: Institute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstraße 55, 45147 Essen, Germany. Electronic address: Monika.Lindemann@uk-essen.de.
authors: Monika
authors: M
authors: Lindemann
mesh_terms: D000328:Adult; D000368:Aged; D001402:B-Lymphocytes / Q000276:immunology; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006801:Humans; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D007115:Immunization Schedule; D007371:Interferon-gamma / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000276:immunology*; D013601:T-Lymphocytes / Q000276:immunology; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen; D007371:Interferon-gamma
keywords: Cellular immune response; Hepatitis B Virus; Third generation hepatitis B vaccine; Vaccination failure