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Study on the Safety and Efficacy of a Hepatitis B Vaccine with Hepatitis B Surface Antigen (rDNA), MVA-HBVAC, and Mosaic HBcoreAg for Adults with Chronic Hepatitis B

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called chronic hepatitis B, which is a long-lasting infection of the liver caused by the hepatitis B virus. The study is testing a new vaccine treatment called TherVacB. This vaccine is designed to help the immune system fight the hepatitis B virus more effectively. The treatment involves a combination of different vaccine components, including hepatitis B surface antigen (rdna), MVA-HBVAC, and MOSAIC HBCOREAG, all of which are given as injections into the muscle.

The purpose of the study is to assess the safety and how well people can tolerate the new vaccine treatment. Participants will receive the vaccine injections and will be monitored for any side effects or reactions. The study will also look at how the vaccine affects the liver and whether it helps reduce the amount of virus in the body. The trial will take place over a period of time, with participants receiving several injections and attending follow-up visits to check on their health and the vaccine's effects.

Throughout the study, researchers will collect information on any side effects experienced by participants, as well as any changes in their health. The goal is to determine if the vaccine is safe and effective for people with chronic hepatitis B. This research could lead to new treatment options for those living with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have confirmed chronic hepatitis B infection and meet specific health criteria.

    The patient will have provided informed consent to participate in the clinical trial.

  2. Step 2

    Initial assessment

    The patient will undergo a medical history review and physical examination.

    Laboratory tests will be conducted to ensure eligibility based on health parameters.

  3. Step 3

    Vaccination phase

    The patient will receive the TherVacB vaccine, which is a therapeutic hepatitis B vaccine candidate.

    The vaccine will be administered as a solution for injection through intramuscular injection.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored for any adverse events, including local and systemic reactions, within 7 days after each vaccination.

    Regular follow-up visits will be scheduled to assess the patient's health and the vaccine's effects on hepatitis B surface antigen levels.

  5. Step 5

    End of trial

    The trial is expected to conclude by October 2026.

    Final assessments will be conducted to evaluate the safety and efficacy of the vaccine.

Who can join the trial?

11 criteria

  • Must be able to understand the information about the study and personally sign and date the consent form to participate.
  • Must provide written consent to participate.
  • Must have confirmed **chronic hepatitis B** infection, which means:
    • Positive for **HBsAg** (a specific protein related to hepatitis B) for at least 6 months.
    • Negative for **anti-HBs** (antibodies against hepatitis B).
    • HBsAg levels between 100-2000 IU/mL.
    • On **HBV nucleos(t)ide analog (NUC)** treatment for at least 6 months.
    • HBV load (amount of virus in the blood) less than 100 IU/mL at least twice in the last 6 months.
    • Must be a male or a non-pregnant, non-breastfeeding female with a negative pregnancy test, aged between 18 and 70 years at the time of giving consent.
    • Should not have any other significant health problems apart from chronic hepatitis B, as determined by medical history, physical examination, and lab results during the screening visit. Some lab results can be slightly abnormal but should not increase the risk of participating in the study.
    • Can be on regular or occasional medications if they do not pose additional risks to safety or affect the study's assessments, and do not indicate worsening of an existing health condition.
    • Must have a **body mass index (BMI)** between 18.5 and 32.0 kg/m² and weigh more than 50 kg at the screening.

Who cannot join the trial?

5 criteria

  • Individuals who do not have **chronic hepatitis B**. This is a long-lasting infection of the liver caused by the hepatitis B virus.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are not part of the specified clinical trial group.
  • Individuals who are not male or female, as both genders are included in the study.
  • Individuals who are not considered part of a vulnerable population. This refers to groups who may need special protection or care.
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Investigated drugs

TherVacB is a vaccine candidate being tested for its safety, tolerability, and ability to stimulate an immune response against hepatitis B. This vaccine uses a combination approach, starting with a protein-based component to prime the immune system, followed by a boost with a modified virus called MVA. The goal is to help the body recognize and fight the hepatitis B virus more effectively.

What is already known about the treatment

TherVacB – This medication is administered as a vaccine, specifically designed for injection. It is currently in the clinical trial phase, being studied for its safety, tolerability, and ability to stimulate an immune response. The main therapeutic indication for TherVacB is chronic hepatitis B, a liver infection caused by the hepatitis B virus. The vaccine works by priming the immune system with a protein and then boosting it with a modified virus, aiming to enhance the body's ability to fight the infection. TherVacB falls under the pharmacological classification of therapeutic vaccines, which are designed to treat existing diseases by enhancing the immune response.

Investigated diseases

Chronic Hepatitis B – Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. It can lead to inflammation and damage to liver cells over time. The disease progresses slowly, often without noticeable symptoms in the early stages. As the infection persists, it can cause liver scarring, known as fibrosis, and eventually lead to cirrhosis, which is severe liver damage. Some individuals may experience fatigue, jaundice, or abdominal discomfort as the disease advances. The virus can remain in the body for years, potentially leading to complications if not managed properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507623-36-00Protocol codeTherVacB_1b2a_1Estimated enrolment99 patientsSponsorKlinikum Der Universitat Munchen AöR

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