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Chronic Hepatitis BPhase 1NCT05727267

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

A Phase 1 study testing HEPLISAV B; TherVacB and TherVacB in people with Chronic Hepatitis B, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis B
What is being tested?
HEPLISAV B; TherVacB and TherVacB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesGermany
Study dates
23 Jan 2024to 21 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Bernhard Nocht Centre for Clinical Trials (BNCCT)

    Hamburg, 20359

  • Division of Infectious Diseases and Tropical Medicine, LMU Klinikum

    Munich, 80802

Other trials in Germany

About this study

Official title: 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 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

Read the detailed description

The clinical trial is divided into two overlapping parts (part I and part II) in 24 healthy male and female subjects aged 18-65 years.

Part I (N = 11) Protein prime vaccinations two times (day 0 and 28) and MVA based boost vaccination 1 x (day 56) 3 subjects will be allocated to A0 and receive HEPLISAV B® and a boost with MVA-HBVac high dose 3 subjects will be allocated to B0.1 and receive HEPLISAV B® \& HBcoreAg low dose and a boost with MVA-HBVac low dose 5 subjects will be allocated to B0.2 and receive 2 x HEPLISAV B® \& HBcoreAg medium dose and a boost with MVA-HBVac high dose Part II (N = 13) Protein prime vaccinations two times (day 0 and 28) and MVA based boost with MVA-HBVac high dose on day 56 3 subjects will be allocated to C0.1 and receive HBsAg high dose \& HBcoreAg high dose plus boost 5 subjects will be allocated to C0.2 and receive HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose plus boost 5 subjects will be allocated to C0.3 and receive HBsAg high dose + adjuvant \&HBcoreAg high dose plus boost

Being tested
HEPLISAV B; TherVacB, TherVacB
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEPLISAV B; TherVacBBiological

    Administration of the described combinations via the intramuscular route

  • TherVacBBiological

    Administration of the described combinations via the intramuscular route

Study groups in NCT05727267
Study groupRoleWhat they receive
Arm A0ExperimentalHEPLISAV B® and MVA-HBVac high dose
Receives: Biological: HEPLISAV B; TherVacB
Arm B0.1ExperimentalHEPLISAV B® \& HBcoreAg low dose and MVA-HBVac low dose
Receives: Biological: HEPLISAV B; TherVacB
Arm B0.2Experimental2 x HEPLISAV B® \& HBcoreAg medium and MVA-HBVac high dose
Receives: Biological: HEPLISAV B; TherVacB
Arm C0.1ExperimentalHBsAg high dose \& HBcoreAg high dose and MVA-HBVac high dose
Receives: Biological: TherVacB
Arm C0.2ExperimentalHBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose and MVA-HBVac high dose
Receives: Biological: TherVacB
Arm C0.3ExperimentalHBsAg high dose + adjuvant \& HBcoreAg high dose and MVA-HBVac high dose
Receives: Biological: TherVacB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurence of solicited local reactogenicity signs and symptoms (AEs)

    numerbers of solicited AEs for 7 days after each vaccination

    Measured: up to day 63

  2. occurence of unsolicited local reactogenicity signs and symptoms

    numbers of of unsolicited AEs for 28 days after each vaccination

    Measured: up to day 84

  3. changes of safety laboratory measures

    changes of values from safety laboratory measures from baseline

    Measured: up to day 224

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

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

    Measured: up to day 224

Secondary outcomes (3)

  1. Magnitude of anti-HBs antibody responses

    determined by an accredited serological immuno-assay

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

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

    determined by an accredited serological immuno-assay

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

  3. Magnitude of HBV-specific T-cell responses

    determined by cytokine release assays

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start23 Jan 2024
  3. Primary completion21 May 2026
  4. Study completion21 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727267
Sponsor's protocol ID
TherVacB_Phase1
Status last verified
May 2026
First submitted
6 Nov 2022
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEPLISAV B; TherVacB and TherVacB in people with Chronic Hepatitis B, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurence of solicited local reactogenicity signs and symptoms (AEs) (time frame: up to day 63). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05727267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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