TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
NCT06513286 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81
Last updated 2025-07-25
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.
Conditions
Interventions
- BIOLOGICAL
-
TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Administration of the described combinations via the intramuscular route
- BIOLOGICAL
-
TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
Administration of the described combinations via the intramuscular route
Sponsors & Collaborators
-
Institute of Virology Helmholtz Zentrum München Trogerstraße 30 81675 Munich, Germany
collaborator UNKNOWN -
Michael Hoelscher
lead OTHER
Principal Investigators
-
Michael Hoelscher, Prof. Dr. med. · Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-12
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Germany
Study Locations
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