A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

Exclusion Criteria

• •1. Receipt of any vaccine in the 2 weeks prior to first trial vaccination (4 weeks for live vaccines), or planned receipt of any vaccine in the 2 weeks before each trial vaccination (4 weeks for live vaccines) until 3 weeks following each trial vaccination. Exception: Required recommended pandemic and influenza vaccines are allowed.
• •2. Previous hepatitis B vaccination or an anti-HBs positive serum status before study start.
• •3. Immunization with a poxvirus-based viral vector. A suspected or confirmed monkeypox infection within the last 10 years.
• •4. Known allergy to components of the vaccine products (incl. hypersensitivity to yeast) or history of life-threatening reactions to vaccines containing one of the substances.
• •5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
• •6. History of previous HBV infection (if serostatus: anti-HBc positive).
• •7. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
• •8. Evidence for a condition in the subject's medical history or during medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of vaccine pro-ducts.
• •9. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years.
• •10. Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a febrile seizure as a child and occasional migraine headaches.