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Recruiting Phase 4 NCT04588077

Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis

Trial Parameters

Condition Hepatitis B
Sponsor Mercy Medical Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-09-14
Completion 2028-12-01
Interventions
Heplisav-B Injectable Product, 2-dose regimenHeplisav-B Injectable Product, 3-dose regimen

Brief Summary

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.

Eligibility 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.

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