title: Therapeutic vaccination of chronic hepatitis B patients with virus suppression by antiviral therapy: a randomized, controlled study of co-administration of HBsAg/AS02 candidate vaccine and lamivudine.
abstract: Induction of curative immune responses by therapeutic vaccination in chronic viral infections such as chronic hepatitis B (CHB) is expected to be facilitated by reduction of viral load by antiviral treatment. In this open label, controlled, randomized study, 195 patients with HBeAg positive CHB were randomized to receive 12 doses of HBsAg with AS02B adjuvant candidate vaccine plus lamivudine daily for 52 weeks or lamivudine daily alone. The combined administration of vaccine and lamivudine was safe and well tolerated, but did not improve the HBe seroconversion rate (18.8%) when compared to treatment with lamivudine alone (16.1%) (p=0.6824). Despite induction of a vigorous HBsAg-specific lymphoproliferative response, cytokine production and anti-HBs antibodies, therapeutic vaccination with an adjuvanted HBsAg vaccine administered concomitantly with lamivudine did not demonstrate superior clinical efficacy in HBeAg positive CHB patients as compared to lamivudine therapy alone.
authors.affiliation: GlaxoSmithKline Biologicals, 1330 Rixensart, Belgium. pierre.vandepapeliere@gskbio.com
authors.forename: Pierre
authors.initials: P
authors.lastname: Vandepapelière
authors.forename: George K K
authors.initials: GK
authors.lastname: Lau
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.forename: Yves
authors.initials: Y
authors.lastname: Horsmans
authors.forename: Edward
authors.initials: E
authors.lastname: Gane
authors.forename: Tawesak
authors.initials: T
authors.lastname: Tawandee
authors.forename: Mohd Ismail bin
authors.initials: MI
authors.lastname: Merican
authors.forename: Khin Maung
authors.initials: KM
authors.lastname: Win
authors.forename: Christian
authors.initials: C
authors.lastname: Trepo
authors.forename: Graham
authors.initials: G
authors.lastname: Cooksley
authors.forename: Martine
authors.initials: M
authors.lastname: Wettendorff
authors.forename: Carlo
authors.initials: C
authors.lastname: Ferrari
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000276:immunology* / Q000627:therapeutic use*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D019694:Hepatitis B, Chronic / Q000188:drug therapy / Q000628:therapy* / Q000821:virology; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007167:Immunotherapy; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine