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

NCT05727267 | Recruiting Phase 1 DMC

• 1 other identifier: TherVacB_Phase1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (4)

• occurence of solicited local reactogenicity signs and symptoms (AEs)

  numerbers of solicited AEs for 7 days after each vaccination

  up to day 63

• occurence of unsolicited local reactogenicity signs and symptoms

  numbers of of unsolicited AEs for 28 days after each vaccination

  up to day 84

• changes of safety laboratory measures

  changes of values from safety laboratory measures from baseline

  up to day 224

• nature, frequency and severity of adverse events associated with the vaccine

  numbers and severity grade of SAEs throughout the period of the clinical trial

  up to day 224

Secondary Outcomes (3)

• Magnitude of anti-HBs antibody responses

  day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224

• Percentage of participants who seroconvert to anti-HBs (>10 IU/l), anti-HBc or anti-HBs and anti-HBc

  day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224

• Magnitude of HBV-specific T-cell responses

  day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224

Study Arms (6)

Arm A0

EXPERIMENTAL

HEPLISAV B® and MVA-HBVac high dose

Biological: HEPLISAV B; TherVacB

Arm B0.1

EXPERIMENTAL

HEPLISAV B® \& HBcoreAg low dose and MVA-HBVac low dose

Biological: HEPLISAV B; TherVacB

Arm B0.2

EXPERIMENTAL

2 x HEPLISAV B® \& HBcoreAg medium and MVA-HBVac high dose

Biological: HEPLISAV B; TherVacB

Arm C0.1

EXPERIMENTAL

HBsAg high dose \& HBcoreAg high dose and MVA-HBVac high dose

Biological: TherVacB

Arm C0.2

EXPERIMENTAL

HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose and MVA-HBVac high dose

Biological: TherVacB

Arm C0.3

EXPERIMENTAL

HBsAg high dose + adjuvant \& HBcoreAg high dose and MVA-HBVac high dose

Biological: TherVacB

Interventions

HEPLISAV B; TherVacB BIOLOGICAL

Administration of the described combinations via the intramuscular route

Arm A0; Arm B0.1; Arm B0.2

TherVacB BIOLOGICAL

Administration of the described combinations via the intramuscular route

Arm C0.1; Arm C0.2; Arm C0.3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.
• Provided written informed consent.
• Healthy male and female subjects aged 18-65 years at time of informed consent.
• 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.
• 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.
• Body mass index 18.5-32.0 kg/m2 and weight \>50 kg at screening.
• Women of child-bearing potential (WOCBP) only: non-pregnant, non-lactating women with negative pregnancy test.
• WOCBP who agree to comply with the applicable contraceptive requirements of the protocol.

You may not qualify if:

• 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.
• Previous hepatitis B vaccination or an anti-HBs positive serum status before study start.
• Immunization with a poxvirus-based viral vector. A suspected or confirmed monkeypox infection within the last 10 years.
• 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.
• Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
• History of previous HBV infection (if serostatus: anti-HBc positive).
• Clinically relevant findings in ECG or significant thromboembolic events in medical history.
• 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.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years.
• Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a febrile seizure as a child and occasional migraine headaches.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Center for Infection Research: collaborator
• Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf: collaborator
• Helmholtz Zentrum München: collaborator
• The Fraunhofer-Gesellschaft: collaborator
• Institute of Virology Helmholtz Zentrum München (HMGU): collaborator
• LMU Klinikum: collaborator

Study Sites (2)

Bernhard Nocht Centre for Clinical Trials (BNCCT)

Hamburg, 20359, Germany

NOT YET RECRUITING

Division of Infectious Diseases and Tropical Medicine, LMU Klinikum

Munich, 80802, Germany

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Heplisav-B

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marylyn M Addo, Prof

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marylyn M Addo, Prof

CONTACT

+49 40 7410 51102; sekretariataddo@uke.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: February 14, 2023
• Study Start: January 23, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)