In short
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.
Key points
- One clinical trial is investigating Hepatitis B Surface Antigen in cirrhotic patients who did not respond to a standard hepatitis B vaccine series. The study is Phase 2 and compares three vaccine strategies: intramuscular, intradermal, and IMIQUIMOD followed by intradermal vaccination. The main goal is to see how many patients reach an anti-HBs level above 10 mUI/mL, which is used as a marker of vaccine response. The trial includes 60 participants and is completed. It focuses on patients with low antibody levels after previous vaccination.
Trial overview
The provided trial, NCT05028322, is a Phase 2 interventional study with 60 participants and a status of Completed.
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.
Who can participate
The study population is cirrhotic patients who already received a conventional hepatitis B vaccine regimen and still did not respond.
In this trial, poor response was defined as an anti-HBs level below 10 UI/mL at the end of the vaccine regimen.
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.
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.
IMIQUIMOD in this study is a cutaneous treatment, meaning it is applied to the skin, before one of the vaccine strategies.
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.
The study is interventional, which means the researchers assigned different vaccination strategies instead of only observing what happened naturally.
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.
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.
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.
In simple terms, the trial is asking how many patients develop enough antibodies after each vaccination approach.
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.
The main measure is not whether the vaccine was given, but whether the body made enough protective antibodies after the study schedule.
Because the study is completed, its data may help researchers understand which strategy performed better in this difficult-to-treat group.