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Mosaic Hbcoreag

A groundbreaking clinical trial is underway to assess a new therapeutic vaccine for chronic hepatitis B. This innovative approach combines a protein prime with an MVA boost, featuring Mosaic HBcoreAg as a key component. The study aims to evaluate the safety, tolerability, and immune response in adult patients with chronic hepatitis B, potentially offering new hope for those affected by this persistent viral infection.

Table of Contents

What is MOSAIC HBCOREAG?

MOSAIC HBCOREAG is a new therapeutic vaccine being developed to treat chronic hepatitis B. It is part of a vaccine combination called TherVacB, which is currently being studied in clinical trials[1]. This vaccine is different from preventive hepatitis B vaccines that you might have received as a child. Instead, it’s designed to help people who already have chronic hepatitis B fight the virus more effectively.

Target Condition: Chronic Hepatitis B

Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus (HBV). It can lead to serious liver problems if left untreated. The goal of this new vaccine is to help the body’s immune system fight the virus better than current treatments alone[1].

Clinical Trial Details

The clinical trial for MOSAIC HBCOREAG is called TherVacB. It’s a Phase 1b/2a trial, which means it’s one of the early stages of testing in humans. The main goals of this trial are to check if the vaccine is safe and if it can stimulate the immune system to fight hepatitis B[1].

Key points about the trial:

  • It’s a multi-center trial, meaning it’s being conducted at several medical centers.
  • The vaccine is given as a series of injections into the muscle (intramuscular injection).
  • It uses a “prime-boost” strategy, which means different types of vaccines are given in a specific order to improve the immune response.

How the Vaccine Works

MOSAIC HBCOREAG is part of a vaccine strategy that includes:

  1. A protein prime: This is likely a protein that resembles part of the hepatitis B virus.
  2. An MVA boost: MVA stands for Modified Vaccinia Ankara, which is a weakened virus used as a delivery system for the vaccine.

This combination is designed to “teach” your immune system to recognize and fight the hepatitis B virus more effectively[1].

Eligibility Criteria

Not everyone with chronic hepatitis B can participate in this trial. Here are some key eligibility requirements:

  • Age: 18-70 years old
  • Confirmed chronic hepatitis B infection for at least 6 months
  • Currently on hepatitis B treatment (nucleos(t)ide analog) for at least 6 months
  • Low levels of hepatitis B virus in the blood (less than 100 IU/ml)
  • No advanced liver disease or cirrhosis
  • No other significant health problems
  • Not pregnant or breastfeeding

There are also several conditions that would prevent someone from participating, such as other liver diseases, HIV or hepatitis C co-infection, or certain medications that affect the immune system[1].

Safety and Effectiveness Measures

The researchers will be closely monitoring participants for any side effects or safety concerns. They’ll be looking at:

  • Local reactions at the injection site (like pain or swelling)
  • Systemic reactions (like fever or fatigue)
  • Any unexpected side effects
  • Changes in liver function tests

To see if the vaccine is working, they’ll measure:

  • Levels of hepatitis B surface antigen (HBsAg) in the blood
  • Development of antibodies against hepatitis B (anti-HBs)
  • T-cell responses (a type of immune cell) specific to hepatitis B

Potential Benefits

If successful, this vaccine could offer several benefits for people with chronic hepatitis B:

  • Reduction in hepatitis B virus levels in the blood
  • Development of protective antibodies against hepatitis B
  • Improved immune response against the virus
  • Potentially, a functional cure for some patients

It’s important to note that these are potential benefits, and more research is needed to confirm the vaccine’s effectiveness[1].

Aspect Details
Trial Name TherVacB
Trial Phase Phase 1b/2a
Main Objective Assess safety and tolerability of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine
Key Component Mosaic HBcoreAg
Target Population Adults with chronic hepatitis B
Primary Endpoints Adverse events, reactogenicity, liver toxicity
Secondary Endpoints HBsAg reduction, anti-HBs antibody induction, T-cell responses
Administration Route Intramuscular injection

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess the safety and tolerability of a new therapeutic hepatitis B vaccine called TherVacB, which includes Mosaic HBcoreAg. The trial also aims to evaluate the vaccine's ability to stimulate an immune response and its antiviral effects in patients with chronic hepatitis B.
  • Who is eligible to participate in this trial? Eligible participants are adults aged 18-70 with confirmed chronic hepatitis B infection, who have been on nucleos(t)ide analog treatment for at least 6 months, have specific HBsAg levels, and meet other health criteria. Pregnant or lactating women are not eligible.
  • What does the vaccine contain? The vaccine includes Mosaic HBcoreAg, which is a specially designed hepatitis B core antigen. It's part of a 'prime-boost' strategy that combines protein components with an MVA (Modified Vaccinia Ankara) boost to stimulate a stronger immune response.
  • How will the effectiveness of the vaccine be measured? The effectiveness will be measured through various means, including monitoring HBsAg levels, checking for the development of anti-HBs antibodies, and assessing HBV-specific T-cell responses. The goal is to see a significant drop in HBsAg levels and an increase in immune responses against the hepatitis B virus.
  • What are the potential risks of participating in this trial? As with any clinical trial, there may be risks. The study will closely monitor for any adverse events, including local reactions at the injection site, systemic reactions, and any liver-related issues. Participants will be regularly assessed for safety throughout the trial.

Ongoing Clinical Trials on Mosaic Hbcoreag

  • 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 that can lead to serious liver damage if left untreated.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus. Its presence in the blood indicates an active hepatitis B infection.
  • Anti-HBs: Antibodies produced by the immune system against the hepatitis B surface antigen. Their presence usually indicates immunity to hepatitis B.
  • Nucleos(t)ide analog (NUC): A type of antiviral medication used to treat chronic hepatitis B by suppressing the replication of the virus.
  • MVA (Modified Vaccinia Ankara): A weakened form of the vaccinia virus used as a vaccine vector to deliver antigens and stimulate immune responses.
  • Mosaic HBcoreAg: A specially designed hepatitis B core antigen used in the experimental vaccine to stimulate a broader immune response against hepatitis B.
  • Prime-boost strategy: A vaccination approach that uses different types of vaccines in sequence to enhance the immune response.
  • T-cell response: The activation of T lymphocytes (a type of white blood cell) as part of the immune response to a specific antigen.
  • ALT (Alanine aminotransferase): An enzyme found primarily in the liver. Elevated levels can indicate liver damage or inflammation.
  • Reactogenicity: The ability of a vaccine to produce common, expected adverse reactions, usually at the injection site or as mild systemic symptoms.

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/