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

RECRUITINGPhase 4Sponsored by Mercy Medical Center
Actively Recruiting
PhasePhase 4
SponsorMercy Medical Center
Started2020-09-14
Est. completion2028-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04588077

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

Chronic Liver DiseaseCirrhosis, LiverHepatitis BLiver Disease

Interventions2

Heplisav-B Injectable Product, 2-dose regimenHeplisav-B Injectable Product, 3-dose regimen

Locations1 site

Mercy Medical Center
Baltimore, Maryland, 21202
CHAU TO, MD714-400-1331cto@mdmercy.com

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