RecruitingPhase 4NCT04588077

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

Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.


Sponsor

Mercy Medical Center

Enrollment

200 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • \- 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 Criteria4

  • 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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Interventions

BIOLOGICALHeplisav-B Injectable Product, 2-dose regimen

Investigators will randomly assign patients into a 2-dose regimen.

BIOLOGICALHeplisav-B Injectable Product, 3-dose regimen

Investigators will randomly assign patients into a 3-dose regimen.


Locations(1)

Mercy Medical Center

Baltimore, Maryland, United States

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NCT04588077


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