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

Launched by MERCY MEDICAL CENTER · Oct 8, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well two different vaccination schedules for the hepatitis B vaccine, called Heplisav B, work for patients with cirrhosis, which is a serious liver condition. The researchers want to see if getting two doses of the vaccine is just as effective as getting three doses in helping patients develop immunity against hepatitis B. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with cirrhosis, and do not already have immunity to hepatitis B. This is determined by a simple blood test.

If you or someone you know is interested in participating, you can expect to visit the hepatology clinic at Mercy Medical Center, where you will receive the vaccine according to the schedule assigned to you. Participants will be monitored to see how well their immune system responds to the vaccine. However, there are some important exclusions: if you have had a serious allergic reaction to the vaccine or its components, have already been exposed to hepatitis B, or have had a liver transplant, you would not be eligible to participate.

Gender

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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.