Table of Contents
- Trial overview
- Who can participate
- What is being studied
- Trial phase and design
- Outcomes being measured
- What the results mean for patients
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]
