Comparing 2-dose and 3-dose hepatitis B vaccine regimens in cirrhosis patients
Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.
This study is testing whether giving two or three doses of the hepatitis B vaccine works better for people with cirrhosis who need protection against the virus.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mercy Medical Center Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04588077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with cirrhosis who lack immunity against hepatitis B.
Not a fit: Patients who have previously been vaccinated against hepatitis B or have had a serious allergic reaction to the vaccine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for hepatitis B in patients with cirrhosis, potentially reducing the risk of severe liver disease.
How similar studies have performed: While there have been studies on hepatitis B vaccination, this specific comparison of 2-dose versus 3-dose regimens in cirrhosis patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.