A new therapeutic vaccine for chronic Hepatitis B

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

This study is testing a new vaccine for chronic Hepatitis B to see how well it can boost the immune response in healthy adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Universitätsklinikum Hamburg-Eppendorf (other)
• Locations: 2 sites (Hamburg and 1 other locations)
• Trial ID: NCT05727267 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, ascending dose phase 1a trial designed to evaluate the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine. It involves two parts with a total of 24 healthy participants aged 18-65, who will receive different combinations of HEPLISAV B and MVA-HBVac vaccinations. The first part focuses on various dosing regimens of the vaccine, while the second part continues to assess different combinations and dosages to determine the most effective approach. The study aims to gather data on how well the vaccine stimulates the immune response against hepatitis B.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male and female adults aged 18-65 with no significant health issues.

Not a fit: Patients with clinically significant health problems or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new therapeutic option for individuals with chronic Hepatitis B, potentially improving their immune response and health outcomes.

How similar studies have performed: While there have been various approaches to hepatitis B vaccination, this specific combination of therapies is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Hamburg and 1 other locations

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

Study contacts

• Principal investigator: Marylyn M Addo, Prof — Universitätsklinikum Hamburg-Eppendorf
• Study coordinator: Marylyn M Addo, Prof

Conditions: Chronic Hepatitis B