Comparing 2-dose and 3-dose hepatitis B vaccine regimens in cirrhosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of two-dose versus three-dose regimens of the Heplisav B hepatitis B vaccine in patients with cirrhosis. It is a randomized prospective trial that will assess seroconversion rates, defined by the presence of antibodies against hepatitis B, after vaccination. The study will involve patients over 18 years old who do not have immunity against hepatitis B and will monitor their immune response through blood tests conducted 8 to 12 weeks post-vaccination. The goal is to determine which regimen provides better protection against hepatitis B in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- All the cirrhosis patients more than 18 years old presented to the hepatology clinic in Mercy Medical Center between 09/2020 and 07/2021 who do not have immunity against Hepatitis B (defined as anti-HBs titer \< 10 mIU/ml) will be recruited.

Exclusion Criteria:

* Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine.
* Those who had previous exposure to hepatitis B.
* Post liver transplant patients.
* Less than 18 years old.

Where it's running

• Mercy Medical Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Paul Thuluvath, MD — Mercy Medical Center
• Study coordinator: Chau to, Md
• Email: cto@mdmercy.com
• Phone: (714)-400-1331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.