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Hepatitis B Surface Antigen

Clinical trials investigating Hepatitis B Surface Antigen are studying vaccine response in cirrhotic patients who did not respond to standard hepatitis B vaccination. These trials evaluate safety and effectiveness of different vaccine strategies, including intramuscular and intradermal use, sometimes after IMIQUIMOD application.

Table of Contents

Trial overview

The provided trial, NCT05028322, is a Phase 2 interventional study with 60 participants and a status of Completed.[1]

It studies Hepatitis B Surface Antigen as part of hepatitis B vaccination strategies in cirrhotic patients who did not respond to a previous standard vaccine regimen.[1]

Who can participate

The study population is cirrhotic patients who already received a conventional hepatitis B vaccine regimen and still did not respond.[1]

In this trial, poor response was defined as an anti-HBs level below 10 UI/mL at the end of the vaccine regimen.[1]

What is being studied

The trial compares three vaccine strategies using Hepatitis B Surface Antigen: simple intramuscular vaccination, simple intradermal vaccination, and IMIQUIMOD applied on the skin before intradermal vaccination.[1]

The brief summary says the schedule uses a M0-M1-M6 regimen, which means doses are given at the start, then at month 1, and then at month 6.[1]

IMIQUIMOD in this study is a cutaneous treatment, meaning it is applied to the skin, before one of the vaccine strategies.[1]

Trial phase and design

This is a Phase 2 study, so it is looking at how well the vaccine strategies work in this specific patient group while also monitoring safety.[1]

The study is interventional, which means the researchers assigned different vaccination strategies instead of only observing what happened naturally.[1]

The interventions listed in the source are Hepatitis B Surface Antigen given by intramuscular injection or intradermal use, plus IMIQUIMOD by cutaneous use in one strategy.[1]

Outcomes being measured

The primary outcome is the proportion of patients with an anti-HBs antibody level greater than 10 mUI/mL at month 7 from the first injection.[1]

The brief summary also describes the same idea at one month after the last vaccine injection, comparing the three strategies to see which one leads to a better antibody response.[1]

In simple terms, the trial is asking how many patients develop enough antibodies after each vaccination approach.[1]

What the results mean for patients

For patients with cirrhosis who did not respond to standard hepatitis B vaccination, this trial explores whether a different vaccination route or the use of IMIQUIMOD before vaccination may improve the immune response.[1]

The main measure is not whether the vaccine was given, but whether the body made enough protective antibodies after the study schedule.[1]

Because the study is completed, its data may help researchers understand which strategy performed better in this difficult-to-treat group.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05028322Phase 2Cirrhotic patients who did not respond to conventional hepatitis B vaccinationCompleted60

FAQ

  • Who can take part in trials studying Hepatitis B Surface Antigen? In the trial data provided, participants are cirrhotic patients who already received a standard hepatitis B vaccine regimen but did not respond well. Non-response was defined as an anti-HBs level below 10 UI/mL after the vaccine series.
  • What is being compared in these trials? The trial compares three vaccine strategies: simple intramuscular vaccination, simple intradermal vaccination, and IMIQUIMOD application followed by intradermal vaccination. The goal is to see which approach gives a better antibody response.
  • What phase is the trial? The study is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to monitor safety.
  • What condition is being studied? The condition studied is poor response to hepatitis B vaccination in cirrhotic patients. The trial focuses on people who did not reach the expected antibody level after a conventional vaccine regimen.
  • What result is the main trial measuring? The main endpoint is the proportion of patients with anti-HBs antibody levels greater than 10 mUI/mL at month 7 from the first injection. This shows how many patients developed a protective antibody response.

Ongoing Clinical Trials on Hepatitis B Surface Antigen

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

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Cirrhosis: A long-term liver disease that causes scarring of the liver and can affect how the body responds to vaccines and treatments.
  • Anti-HBs: A blood antibody measured after hepatitis B vaccination. It shows whether the body has made a response to the vaccine.
  • Antibody: A protein made by the immune system to fight infection or respond to a vaccine.
  • Non-responder: A person who does not make enough antibodies after a vaccine series.
  • Intramuscular injection: A shot given into a muscle.
  • Intradermal use: A medicine or vaccine given into the skin layer just under the surface.
  • IMIQUIMOD: A cream used on the skin in this trial before one of the vaccine strategies.
  • Phase 2: A stage of clinical research that checks whether a treatment seems to work and continues to watch safety.
  • Primary outcome: The main result a trial measures to decide if the strategy worked.
  • Enrollment: The number of people included in a study.

References