Pierre VandepapelièreGeorge K.K. LauGeert Leroux-RoelsYves HorsmansEdward GaneTawesak TawandeeMohd Ismail bin MericanKhin Maung WinChristian TrepoGraham CooksleyMartine WettendorffCarlo FerrariQueen Mary Hospital Hong KongUniversiteit GentCliniques Universitaires Saint-Luc, BrusselsMiddlemore Hospital, AucklandMahidol UniversityKuala Lumpur HospitalYangon General HospitalHopital de l'Hotel-Dieu CHU LyonUniversity of QueenslandGlaxosmithkline Biologicals S.A.Universita degli Studi di Parma2018-08-242018-08-242007-12-12Vaccine. Vol.25, No.51 (2007), 8585-85970264410X2-s2.0-36549028324https://repository.li.mahidol.ac.th/handle/20.500.14594/24062Induction 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. © 2007 Elsevier Ltd. All rights reserved.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyImmunology and MicrobiologyMedicineVeterinaryArticleSCOPUS10.1016/j.vaccine.2007.09.072