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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

TherVacB - A Multi-center Phase 1b/2a Trial to Assess Safety, Tolerability and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (NCT06513286) is a Phase 1 / Phase 2 interventional studying Chronic Hepatitis B, sponsored by Michael Hoelscher. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Chronic Hepatitis B, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 81 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Hepatitis B subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Ability to understand the subject information and to personally name, sign and date the willing to sign a consent form to participate in the clinical trial. 2. Provided written willing to sign a consent form. 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 willing to sign a consent form. 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. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Investigational Site GUF
Frankfurt, Germany
Investigational Site UKE
Hamburg, Germany
Investigational Site MHH
Hanover, Germany
Investigational Site Uni Leipzig
Leipzig, Germany
Investigational Site LMU
Munich, Germany
Investigational Site TUM
Munich, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06513286), the sponsor (Michael Hoelscher), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06513286 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06513286?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06513286?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06513286. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06513286. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.