AzTrials
AzTrials

Chronic Hepatitis BPhase 1/2TherVacBNCT06513286

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

A Phase 1/2 study testing TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac) and TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac) in people with Chronic Hepatitis B, run by Michael Hoelscher at 6 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac) and TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
6 sitesGermany
Study dates
12 Jun 2025to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • 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.
  • 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
Show all 19Show fewer
  • HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months
  • HBV load < 100 IU/ml at least twice within the last 6 months
  • Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.
  • 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.
  • 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.
  • Body mass index 18.5-32.0 kg/m2 and weight >50 kg at screening.

Who cannot join

  • Known liver disease other than hepatitis B
  • Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
  • WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol
  • History of hepatocellular carcinoma
  • Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)
  • Regular alcohol intake >30 g/d (male), >20 g/d (female) or any other known drug addiction.
Show all 23Show fewer
  • 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).
  • 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.
  • Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination)
  • 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.
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
  • 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 products.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the first dose of the trial vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years.
  • 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.
  • Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches.
  • Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP.
  • 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.
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Otto Geisenberger, Dr.rer.nat. contact

+49-89-4400598 ext. -26

otto.geisenberger@med.uni-muenchen.de

6 sites in 1 country

Germany6 sites, 6 recruiting

  • Investigational Site GUF

    Frankfurt, 60590

    Recruiting

  • Investigational Site UKE

    Hamburg, 20246

    Recruiting

  • Investigational Site MHH

    Hanover, 30625

    Not yet recruiting

  • Investigational Site Uni Leipzig

    Leipzig, 04103

    Recruiting

  • Investigational Site LMU

    Munich, 81337

    Recruiting

  • Investigational Site TUM

    Munich, 81675

    Recruiting

Other trials in Germany

About this study

Official title: 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

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.

Read the detailed description

This is a multi-centre study conducted in 81 participants. The clinical trial is divided into two overlapping parts (part A and B).

All treatment groups of Part A will receive a single dose of HEPLISAV B on Day 1 and Day 29 and MVA-HBVac on Day 56. From study arm A2 on all participants also receive HBcoreAg, in a low dose in arms A2 and A3 and in a medium dose in arm A4. In arms A5 and A6 either the low or the medium dose will be applied to an extended number of participants. The MVA-HBVac booster dose will be given in a dose-escalating way with a low dose in arms A1 and A2 and a high dose in arms A3, A4, A5 and A6.

The treatment group in Part B, study arm B1 will receive two doses of HEPLISAV B together with HBcoreAg in a high dose (on day 1 and 29), and a high booster dose of MVA-HBVac on day 56. In arm B2 either the regimen of B1 or A5 will be applied to an extended number of participants.

Being tested
TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac), TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
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.

  • TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)Biological

    Administration of the described combinations via the intramuscular route

  • TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)Biological

    Administration of the described combinations via the intramuscular route

Study groups in NCT06513286
Study groupRoleWhat they receive
Arm A1ExperimentalHEPLISAV B® (low dose) and MVA-HBVac (low dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm A2ExperimentalHEPLISAV B® (low dose) \& HBcoreAg (low dose) and MVA-HBVac (low dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm A3ExperimentalHEPLISAV B® (low dose) \& HBcoreAg (low dose) and MVA-HBVac (high dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm A4ExperimentalHEPLISAV B® (low dose) \& HBcoreAg (medium dose) and MVA-HBVac (high dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm A5 (Europe)ExperimentalHEPLISAV B® (low dose) \& HBcoreAg (low dose) and MVA-HBVac (high dose) or HEPLISAV B® (low dose) \& HBcoreAg (medium dose) and MVA-HBVac (high dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm A6 (Tanzania)ExperimentalHEPLISAV B® (low dose) \& HBcoreAg (low dose) and MVA-HBVac (high dose) or HEPLISAV B® (low dose) \& HBcoreAg (medium dose) and MVA-HBVac (high dose)
Receives: Biological: TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Arm B1ExperimentalHEPLISAV B® (high dose) \& HBcoreAg (high dose) and MVA-HBVac (high dose)
Receives: Biological: TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
Arm B2ExperimentalHEPLISAV B® (high dose) \& HBcoreAg (high dose) and MVA-HBVac (high dose) or regimen of study arm A5
Receives: Biological: TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)

What is being measured

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

  1. Frequencies and magnitudes of unsolicited adverse events

    Reported numbers and severity grade of unsolicited AEs for 28 days after each vaccination

    Measured: up to day 84

  2. Frequencies and magnitudes of serious adverse events (SAEs) throughout the trial period

    Reported numbers and types of SAEs throughout the period of the clinical trial

    Measured: up to day 224

  3. Frequencies and magnitudes of adverse event of special interest (AESI) and Suspected Unexpected Serious Adverse Reaction (SUSAR) throughout the trial period

    Reported numbers and severity grade of AESIs and numbers and types of SUSARs

    Measured: up to day 224

  4. Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination

    Reported numbers and severity of solicited AEs

    Measured: up to day 63

  5. Frequencies and magnitudes of solicited systemic reactogenicity signs and symptoms within 7 days after each vaccination

    Reported numbers and severity of solicited AEs

    Measured: up to day 63

  6. Frequencies and magnitudes of liver toxicity (ALT flare-ups) stratified by severity throughout the trial period

    Reported numbers and severity grade of AESIs

    Measured: up to day 224

  7. Change from baseline of safety laboratory measurements throughout the trial period

    Changes of values from safety laboratory measurements from baseline

    Measured: up to day 224

Secondary outcomes (5)

  1. Frequency of subjects with HBsAg drop below the lower limit of quantification

    Determined by an accredited serological immuno-assay

    Measured: 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit).

  2. Frequency of subjects with a ≥ 1 log10 drop in HBsAg titers from day 0 (start of study medication) with the goal of 30% of patients achieving a ≥ 1log10 HBsAg drop

    Determined by an accredited serological immuno-assay

    Measured: 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit

  3. Frequency of subjects with an induction of anti-HBs titers ≥ 10 IU/L

    Determined by an accredited serological immuno-assay

    Measured: 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit

  4. Frequency of subjects developing any anti-HBs antibody response

    Determined by an accredited serological immuno-assay

    Measured: 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit

  5. Frequency of subjects with an increased signal in the HBV-specific cytokine-secretion assay compared to pretreatment values

    Determined by cytokine release assays

    Measured: 2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit

Timeline

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

  1. First posted22 Jul 2024
  2. Study start12 Jun 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06513286
Sponsor's protocol ID
TherVacB_1b2a_1
Acronym
TherVacB
Status last verified
Jun 2026
First submitted
11 Jun 2024
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing plan is in preparation

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac) and TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac) in people with Chronic Hepatitis B, run by Michael Hoelscher at 6 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 19 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 11 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 6 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Otto Geisenberger, Dr.rer.nat. (+49-89-4400598 ext. -26, otto.geisenberger@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequencies and magnitudes of unsolicited adverse events (time frame: up to day 84). The study lists 7 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 NCT06513286.

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 11 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in