TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMichael Hoelscher
About this trial
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.
Eligibility criteria
Qualifiers
Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.
Provided written informed consent.
HBsAg positive for ≥ 6 months
Anti-HBs negative
Disqualifiers
Known liver disease other than hepatitis B
Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol
History of hepatocellular carcinoma
Trial design
Treatments tested in this trial
- TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
- TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
Treatment groups
81 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Michael Hoelscher
Lead sponsor
Ludwig-Maximilians - University of Munich
Sponsor institution
Institute of Virology Helmholtz Zentrum München Trogerstraße 30 81675 Munich, Germany
Collaborator
Source ClinicalTrials.gov