A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
NCT05727267 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-04-24
Summary
This study is an open-label, ascending dose phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine
Conditions
Interventions
- BIOLOGICAL
-
HEPLISAV B; TherVacB
Administration of the described combinations via the intramuscular route
- BIOLOGICAL
-
TherVacB
Administration of the described combinations via the intramuscular route
Sponsors & Collaborators
-
German Center for Infection Research
collaborator OTHER -
Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf
collaborator UNKNOWN -
Helmholtz Zentrum München
collaborator INDUSTRY -
The Fraunhofer-Gesellschaft
collaborator OTHER -
Institute of Virology Helmholtz Zentrum München (HMGU)
collaborator UNKNOWN -
LMU Klinikum
collaborator OTHER -
Universitätsklinikum Hamburg-Eppendorf
lead OTHER
Principal Investigators
-
Marylyn M Addo, Prof · Universitätsklinikum Hamburg-Eppendorf
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-23
- Primary Completion
- 2026-02-28
- Completion
- 2026-06-30
Countries
- Germany
Study Locations
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