A first-time-in human (FTIH), Phase I/II, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GSK Biologicals’ HBV viral vector vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tide analogue (NA) therapy.

Chronic, Hepatitis B

"• Occurrence of AEs from vaccination up to Day 337:  Occurrence of each solicited local and general symptoms within 7 days after each vaccination (from day of vaccination to six days after vaccination).  Occurrence of unsolicited AEs within 30 days after each vaccination (from day of vaccination to 29 days after vaccination).  Occurrence of hematological, biochemical or urinalysis laboratory abnormalities within 30 days after each vaccination . ", " Occurrence of SAEs up to six months after the last dose (Day 337, Visit 22).  Occurrence of pIMDs up to six months after the last dose (Day 337, Visit 22).  Occurrence of liver-disease related AEs up to six months after the last dose (Day 337, Visit 22).  Occurrence of hematological AESIs up to six months after the last dose (Day 337, Visit 22).  Occurrence of medically attended events (MAEs) up to six months after the last dose (Day 337, Visit 22). "

"Immunogenicity Immunogenicity with respect to HBV components of the viral vectored vaccines and adjuvanted proteins vaccines, at predefined time points (see Table 4 and Table 5). • Anti-HBc antibodies: seropositivity and concentration. • Anti-HBs antibodies: seroconversion and concentration; anti-HBs ≥10 mIU/ml and ≥100 mIU/ml. • Frequency of HBc- and HBs- specific CD4+ T-cells and CD8+ T-cells; CD4+ T-cells responder, CD8+ T-cells responder.", "Efficacy • qHBsAg: number of patients with ≥ 0.5 log decrease, ≥ 1-log decrease, HBsAg loss and log-changes since pre-vaccination. • Number of patients with HBsAg loss and anti-HBs seroconversion. • Mean qHBsAg in each group. ", "Safety • Occurrence of AEs from vaccination up to Day 841:  Occurrence of any SAEs throughout the study period,  Occurrence of SAEs causally related to an investigational vaccine throughout the study period,  Occurrence of MAEs throughout the study period,  ", " Occurrence of pIMDs throughout the study period,  Occurrence of liver disease-related AEs throughout the study period,  Occurrence of spontaneous local or general bleeding with thrombocytopenia (< 50,000 platelets/mm3),  Occurrence of anemia with Hb < 9.5 g/dl,  Occurrence of AEs and SAEs leading to study withdrawal. • Pregnancy and pregnancy outcome throughout the study period. "

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