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Mva-Hbvac

A groundbreaking clinical trial is underway to assess the safety, tolerability, and effectiveness of a new hepatitis B vaccine called MVA-HBVac. This innovative vaccine is being tested in adult patients with chronic hepatitis B, offering hope for improved treatment options. The study, known as TherVacB, is a multi-center phase 1b/2a trial that aims to explore the potential of this therapeutic vaccine in combating chronic hepatitis B infection.

Table of Contents

What is MVA-HBVAC?

MVA-HBVAC is a new therapeutic vaccine being developed to treat chronic hepatitis B. It is part of a treatment approach called TherVacB, which combines different types of vaccines to boost the immune system’s response against the hepatitis B virus[1]. The vaccine is currently being studied in a clinical trial to assess its safety and effectiveness in adult patients with chronic hepatitis B.

Target Condition: Chronic Hepatitis B

Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus. It can lead to serious liver problems if left untreated. Current treatments can control the virus but rarely cure the infection completely. MVA-HBVAC aims to help the body’s immune system fight the virus more effectively[1].

How MVA-HBVAC Works

MVA-HBVAC is part of a “heterologous prime/boost” vaccination strategy. This means it’s used in combination with other vaccine components:

  1. Prime: First, patients receive a protein-based vaccine to “prime” the immune system.
  2. Boost: Then, MVA-HBVAC is given to “boost” the immune response further.
This approach aims to stimulate a stronger and more effective immune response against the hepatitis B virus[1].

Clinical Trial Details

The clinical trial for MVA-HBVAC, called TherVacB, is a Phase 1b/2a study. This means it’s an early-stage trial focused on:

  • Assessing the safety and tolerability of the vaccine
  • Evaluating how well the immune system responds to the vaccine
  • Measuring the vaccine’s effect on the hepatitis B virus
The trial is being conducted at multiple medical centers, involving adult patients with chronic hepatitis B[1].

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key requirements include:

  • Age 18-70 years
  • Confirmed chronic hepatitis B infection for at least 6 months
  • Currently on hepatitis B treatment (nucleos(t)ide analogs) for at least 6 months
  • Low levels of hepatitis B virus in the blood
  • No advanced liver disease or other significant health problems
There are also several exclusion criteria, such as co-infection with other viruses like HIV or hepatitis C[1].

Potential Benefits

The researchers hope that MVA-HBVAC, as part of the TherVacB treatment, will:

  • Reduce levels of hepatitis B surface antigen (HBsAg) in the blood
  • Stimulate the production of protective antibodies against hepatitis B
  • Increase the number and activity of immune cells that can fight the virus
These outcomes could potentially lead to better control of the hepatitis B infection and improved liver health[1].

Safety Considerations

As with any new treatment, safety is a top priority. The trial will closely monitor:

  • Side effects at the injection site and throughout the body
  • Any serious adverse events
  • Liver function to ensure the vaccine doesn’t cause liver damage
Patients in the trial will be regularly checked and tested to ensure their safety throughout the study[1].

Aspect Details
Trial Name TherVacB
Trial Phase Phase 1b/2a
Target Condition Chronic hepatitis B
Vaccine Name MVA-HBVac
Administration Route Intramuscular injection
Primary Objectives Safety and tolerability assessment
Secondary Objectives Antiviral effect and immunogenicity evaluation
Key Inclusion Criteria Adults 18-70 years, confirmed chronic HBV, on NUC treatment for ≥6 months
Key Exclusion Criteria Advanced liver fibrosis, cirrhosis, hepatocellular carcinoma, coinfections
Primary Endpoints Adverse events, reactogenicity, liver toxicity
Secondary Endpoints HBsAg reduction, anti-HBs induction, T-cell responses

FAQ

  • What is MVA-HBVac? MVA-HBVac is a new hepatitis B vaccine being tested in clinical trials. It is designed as a therapeutic vaccine, which means it's intended to treat people who already have chronic hepatitis B, rather than prevent the infection in healthy individuals.
  • Who can participate in this clinical trial? The trial is open to adults aged 18-70 years with confirmed chronic hepatitis B infection. Participants must have been on nucleos(t)ide analog treatment for at least 6 months and meet specific criteria regarding their HBV levels and liver function.
  • What are the main objectives of the TherVacB trial? The primary objectives are to assess the safety and tolerability of the MVA-HBVac vaccine. Secondary objectives include evaluating its antiviral effect and its ability to stimulate an immune response against the hepatitis B virus.
  • How is the vaccine administered? The MVA-HBVac vaccine is administered through intramuscular injection. The trial uses a heterologous prime/boost approach, which means participants receive different types of vaccines in a specific sequence to enhance the immune response.
  • What are the potential benefits of participating in this trial? Participants may benefit from a potentially improved treatment for chronic hepatitis B. The trial aims to reduce hepatitis B surface antigen levels and stimulate the production of protective antibodies, which could lead to better control of the virus.

Ongoing Clinical Trials on Mva-Hbvac

  • 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

    Recruiting

    1 1 1
    Investigated drugs:
    Germany Spain

Glossary

  • Chronic hepatitis B: A long-lasting liver infection caused by the hepatitis B virus, which can lead to serious liver damage if left untreated.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus that indicates ongoing infection when present in the blood.
  • Anti-HBs: Antibodies against the hepatitis B surface antigen, which typically indicate immunity to hepatitis B.
  • Nucleos(t)ide analog (NUC): A type of antiviral medication used to treat chronic hepatitis B by suppressing viral replication.
  • ALT: Alanine aminotransferase, a liver enzyme that can indicate liver damage when elevated.
  • AST: Aspartate aminotransferase, another liver enzyme that can indicate liver damage when elevated.
  • Transient elastography: A non-invasive method to assess liver stiffness, which can indicate the presence of fibrosis or cirrhosis.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • MVA: Modified Vaccinia Ankara, a weakened form of the vaccinia virus used as a vaccine vector in this study.
  • Heterologous prime/boost: A vaccination strategy that uses different types of vaccines for the initial dose (prime) and subsequent doses (boost) to enhance immune response.

References

  1. http://clinicaltrials.eu/trial/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/