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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

TherVacB_Phase1a: Open Phase 1a Trial to Assess the Safety and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate in Healthy Volunteers

A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (NCT05727267) is a Phase 1 interventional studying Chronic Hepatitis B, sponsored by Universitätsklinikum Hamburg-Eppendorf. 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 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine

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.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Key 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. Healthy male and female subjects aged 18-65 years at time of willing to sign a consent form. 4. No clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at screening visit. The following laboratory parameters should be within normal limits: WBC, ANC, platelets. AST and ALT should be ≤ULN, CrCL \>60mL/min and total bilirubin should not exceed 1,5 x ULN. 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. 5. Participant may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition. 6. Body mass index 18.5-32.0 kg/m2 and weight \>50 kg at screening. 7. Women of child-bearing potential (WOCBP) only: non-pregnant, non-lactating women with negative pregnancy test. 8. WOCBP who agree to comply with the applicable contraceptive requirements of the protocol. Key Who Should NOT Join This Trial: 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. ...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
Key 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. Healthy male and female subjects aged 18-65 years at time of informed consent. 4. No clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at screening visit. The following laboratory parameters should be within normal limits: WBC, ANC, platelets. AST and ALT should be ≤ULN, CrCL \>60mL/min and total bilirubin should not exceed 1,5 x ULN. 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. 5. Participant may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition. 6. Body mass index 18.5-32.0 kg/m2 and weight \>50 kg at screening. 7. Women of child-bearing potential (WOCBP) only: non-pregnant, non-lactating women with negative pregnancy test. 8. WOCBP who agree to comply with the applicable contraceptive requirements of the protocol. Key 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.

Treatments Being Tested

BIOLOGICAL

HEPLISAV B; TherVacB

Administration of the described combinations via the intramuscular route

BIOLOGICAL

TherVacB

Administration of the described combinations via the intramuscular route

Locations (2)

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.

Bernhard Nocht Centre for Clinical Trials (BNCCT)
Hamburg, Germany
Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Munich, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05727267), the sponsor (Universitätsklinikum Hamburg-Eppendorf), 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 NCT05727267 clinical trial studying?

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

Who can participate in NCT05727267?

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 NCT05727267?

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 NCT05727267. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05727267. 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 2026-05-08 · Data from ClinicalTrials.gov.