Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
Recruiting · NCT04588077 · Interventional (participants receive a specific treatment) · Lead sponsor: Mercy Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Heplisav-B Injectable Product, 2-dose regimenHeplisav-B Injectable Product, 3-dose regimen
What this trial is about
Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Mercy Medical Center - Baltimore, Maryland, United States