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Study on the Effectiveness and Safety of Hepatitis B Surface Antigen and Imiquimod in Cirrhotic Patients Unresponsive to Conventional Vaccination

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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 patients with cirrhosis, a condition where the liver is severely scarred, who have not responded to the usual Hepatitis B vaccination. The study aims to test the effectiveness and safety of a new vaccination method. The treatment involves using a cream called IMIQUIMOD, which is applied to the skin, followed by an intradermal (under the skin) injection of the Hepatitis B Surface Antigen vaccine. This approach is being compared to the traditional intramuscular (into the muscle) vaccine method.

The purpose of the study is to see if this new method can help patients develop a better immune response, measured by the level of antibodies in the blood, which are proteins that help fight infections. The study will follow participants over a period of six months, with vaccinations given at the start, one month, and six months. Researchers will check the antibody levels at different times to see how well the body is responding to the vaccine.

Participants will be divided into groups to receive either the traditional intramuscular vaccine, the intradermal vaccine, or the intradermal vaccine after applying the IMIQUIMOD cream. The study will also monitor any side effects from the treatments. The goal is to find out which method is most effective in helping cirrhotic patients who did not respond to the conventional vaccine regimen to develop protective levels of antibodies against Hepatitis B.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying that the patient is an adult with cirrhosis, not caused by chronic hepatitis B infection, and has not responded to a previous hepatitis B vaccination.

    The patient must have a level of antibodies against hepatitis B surface antigen (HBs) less than 10 mUI/mL after the initial vaccine regimen.

  2. Step 2

    Informed consent

    The patient receives detailed information about the trial and signs an informed consent form, acknowledging understanding of the trial procedures and objectives.

  3. Step 3

    Treatment group assignment

    The patient is assigned to one of three treatment groups: intramuscular vaccine, intradermal vaccine, or intradermal vaccine following the application of Imiquimod cream.

  4. Step 4

    Application of imiquimod (if applicable)

    For patients in the group receiving Imiquimod, the cream is applied to the skin before the intradermal vaccine. This step is specific to the group using the combination of Imiquimod and the vaccine.

  5. Step 5

    Vaccine administration

    The patient receives the hepatitis B vaccine according to their assigned group: intramuscularly or intradermally. The vaccine is administered at the start of the trial (M0), one month later (M1), and six months later (M6).

  6. Step 6

    Monitoring and follow-up

    The patient's antibody levels are monitored at one month (M1), six months (M6), and seven months (M7) after the initial injection to assess the effectiveness of the vaccine strategy.

    The occurrence of any side effects, particularly at the injection or application site, is recorded and evaluated.

  7. Step 7

    Final assessment

    At the end of the trial, the patient's antibody levels are measured to determine if they exceed 10 mUI/mL, indicating a successful response to the vaccination strategy.

Who can join the trial?

5 criteria

  • Must be an adult over 18 years old.
  • Must be a cirrhotic patient, which means having liver damage, but not due to chronic hepatitis B infection.
  • Must have previously received a hepatitis B vaccination in the usual way but did not respond to it. This is shown by having a low level of protective antibodies in the blood.
  • Must be affiliated with a social security plan, which means having some form of health insurance or coverage.
  • Must have received complete information about the research study and signed a document agreeing to participate, known as informed consent.

Who cannot join the trial?

1 criterion

  • Patients who have already received a hepatitis B virus (HBV) vaccination with a standard schedule and did not respond to it. This means their level of antibodies, which are proteins the body makes to fight infections, is less than 10 UI/ml after finishing the vaccine schedule.
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  • Responsive

    CHRU De Nancy

    FranceVandoeuvre Les Nancy, France

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Investigated drugs

  • Hepatitis B Vaccine

    is used in this study to help the body develop immunity against the hepatitis B virus. The vaccine is given in different ways to see which method is most effective for patients with cirrhosis who did not respond to the usual vaccine regimen. Some patients receive the vaccine through a simple intramuscular injection, while others receive it through an intradermal injection, which is just under the skin.

  • Imiquimod

    is a cream applied to the skin before the hepatitis B vaccine is given. It is used in this study to see if it can help improve the body's response to the vaccine when applied topically before the intradermal injection of the vaccine. Imiquimod is known to stimulate the immune system, and researchers are testing if it can enhance the effectiveness of the vaccine in patients who have not responded to the standard vaccination method.

What is already known about the treatment

Imiquimod – This medication is applied topically to the skin and is being studied for its potential to enhance the immune response to vaccines. Currently, it is being investigated in clinical trials for its effectiveness in improving the response to Hepatitis B vaccination in cirrhotic patients who did not respond to a conventional vaccine regimen. Imiquimod works by stimulating the immune system, specifically by activating immune cells to produce cytokines, which help in fighting infections. It is classified as an immune response modifier.

Investigated diseases

Cirrhosis – Cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, leading to impaired liver function. Over time, the liver becomes increasingly unable to perform its vital functions, such as detoxifying the blood, producing proteins, and storing nutrients. The progression of cirrhosis can lead to complications like fluid buildup in the abdomen, bleeding from enlarged veins, and confusion due to toxin buildup. The disease often progresses slowly, and symptoms may not appear until significant liver damage has occurred. Factors contributing to cirrhosis include chronic alcohol consumption, viral hepatitis, and fatty liver disease. As the disease advances, the liver's ability to regenerate is overwhelmed by the ongoing damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514605-61-00Protocol code2020PI198Estimated enrolment60 patientsSponsorCHRU De Nancy

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