NCT06513286 TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
| NCT ID | NCT06513286 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Michael Hoelscher |
| Condition | Chronic Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 81 participants in total. It began in 2025-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial. 2. Provided written informed consent. 3. Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria: * HBsAg positive for ≥ 6 months * Anti-HBs negative * HBsAg levels 100-2000 IU/mL * HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months * HBV load \< 100 IU/ml at least twice within the last 6 months 4. Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent. 5. Apart from CHB no other clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at the screening visit. The following abnormal laboratory parameters will be permitted: * leukocyte count ≥ 2.500/µl * platelet count ≥ 150.000/µl * ALT elevation ≤ 60 U/L * AST should be ≤ 40 U/L * bilirubin should be ≤ ULN * INR should be ≤ ULN * CrCL \> 60mL/min Non-clinically significant, minor deviations of laboratory measurements can be tolerated as they will not increase the risk of the individual having an adverse outcome from participating in this clinical trial as judged by the investigator. 6. Subject may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition. 7. Body mass index 18.5-32.0 kg/m2 and weight \>50 kg at screening. Exclusion Criteria: 1. Known liver disease other than hepatitis B 2. Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition) 3. WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol 4. History of hepatocellular carcinoma 5. Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive) 6. Regular alcohol intake \>30 g/d (male), \>20 g/d (female) or any other known drug addiction. 7. Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to receiving the first dose of the investigational medicinal product (IMP). 8. Receipt of any vaccine in the 2 weeks prior to first trial vaccination (4 weeks for live vaccines), during trial or planned receipt of any vaccine in the 3 weeks following last trial vaccination. Exception: Required recommended pandemic vaccines or emergency vaccines (e.g., tetanus) are allowed. 9. Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination) 10. Known allergy to components of the vaccine products as referred in Table 6 (incl. hypersensitivity to yeast components, E.coli proteins or lipids, duck's or hen's egg white, penicillin, streptomycin, , kanamycin) or history of life-threatening reactions to vaccines containing one of the substances. 11. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines. 12. Clinically relevant findings in ECG or significant thromboembolic events in medical history. 13. 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 products. 14. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the first dose of the trial vaccine. 15. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years. 16. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to systemic corticosteroids, biologicals and Methotrexate) within the last 3 years. Exception: topical corticosteroids, e.g. occasional asthma spays or systemic corticosteroids for medical emergencies. 17. Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches. 18. Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP. 19. Investigator or employee of the study site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study. 20. Subjects who are known or suspected * not to comply with the clinical trial directives. * not to be reliable or trustworthy. * not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed.
Contact & Investigator
Michael Hoelscher, Prof. Dr. med.
STUDY CHAIR
Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Frequently Asked Questions
Who can join the NCT06513286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06513286 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06513286 currently recruiting?
Yes, NCT06513286 is actively recruiting participants. Contact the research team at otto.geisenberger@med.uni-muenchen.de for enrollment information.
Where is the NCT06513286 trial being conducted?
This trial is being conducted at Frankfurt, Germany, Hamburg, Germany, Hanover, Germany, Leipzig, Germany and 2 additional locations.
Who is sponsoring the NCT06513286 clinical trial?
NCT06513286 is sponsored by Michael Hoelscher. The principal investigator is Michael Hoelscher, Prof. Dr. med. at Division of Infectious Diseases and Tropical Medicine, LMU Klinikum. The trial plans to enroll 81 participants.