TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
NCT Number: NCT06513286
Acronym: TherVacB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Hepatitis B
Interventions: BIOLOGICAL: TherVacB (HEPLISAV B)|BIOLOGICAL: TherVacB (HBsAg ± c-di-AMP)
Sponsor: Michael Hoelscher
Collaborators: Institute of Virology Helmholtz Zentrum München Trogerstraße 30 81675 Munich, Germany
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 89
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-12
Locations: Investigational Site UKE, Hamburg, 20246, Germany|Investigational Site MHH, Hannover, 30625, Germany|Investigational Site LMU, Munich, 81337, Germany|Investigational Site TUM, Munich, 81675, Germany

Summary:
This study is an open-label, ascending dose phase 1b/2a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

Primary Outcome Measures: Frequencies and magnitudes of unsolicited adverse events, Reported numbers and severity grade of unsolicited AEs for 28 days after each vaccination, up to day 84|Frequencies and magnitudes of serious adverse events (SAEs) throughout the trial period, Reported numbers and types of SAEs throughout the period of the clinical trial, up to day 224|Frequencies and magnitudes of adverse event of special interest (AESI) and Suspected Unexpected Serious Adverse Reaction (SUSAR) throughout the trial period, Reported numbers and severity grade of AESIs and numbers and types of SUSARs, up to day 224|Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination, Reported numbers and severity of solicited AEs, up to day 63|Frequencies and magnitudes of solicited systemic reactogenicity signs and symptoms within 7 days after each vaccination, Reported numbers and severity of solicited AEs, up to day 63|Frequencies and magnitudes of liver toxicity (ALT flare-ups) stratified by severity throughout the trial period, Reported numbers and severity grade of AESIs, up to day 224|Change from baseline of safety laboratory measurements throughout the trial period, Changes of values from safety laboratory measurements from baseline, up to day 224
Secondary Outcome Measures: Frequency of subjects with HBsAg drop below the lower limit of quantification, Determined by an accredited serological immuno-assay, 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit).|Frequency of subjects with a ≥ 1 log10 drop in HBsAg titers from day 0 (start of study medication) with the goal of 30% of patients achieving a ≥ 1log10 HBsAg drop, Determined by an accredited serological immuno-assay, 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit|Frequency of subjects with an induction of anti-HBs titers ≥ 10 IU/L, Determined by an accredited serological immuno-assay, 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit|Frequency of subjects developing any anti-HBs antibody response, Determined by an accredited serological immuno-assay, 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit|Frequency of subjects with an increased signal in the HBV-specific cytokine-secretion assay compared to pretreatment values, Determined by cytokine release assays, 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit