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Comparing Heplisav B Dosing for Hepatitis B in Cirrhosis

This study is comparing two different ways to give the Heplisav B vaccine to people with cirrhosis (scarring of the liver) who don't have immunity to Hepatitis B. Researchers want to see if giving two doses of Heplisav B (at 0 and 4 weeks) works as well as giving three doses (at 0, 4, and 8 weeks) to protect against Hepatitis B. You might be able to join if you are over 18, have cirrhosis, and don't have immunity to Hepatitis B. The study will look at how many people develop protection against Hepatitis B after getting either two or three doses of the vaccine. The goal is to find the best way to protect people with cirrhosis from Hepatitis B.

Study design
This is an interventional study that plans to enroll 200 participants. Participants will be randomly assigned to receive either a 2-dose or a 3-dose regimen of Heplisav B.
What's involved
Participants will receive either two or three doses of the Heplisav B vaccine. Blood tests will be done at 12 weeks after completing the vaccine series to check for immunity.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 weeks after their last vaccine dose to measure their immune response.

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NCT04588077

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

Recruiting
PHASE4Ages 18+InterventionalPrevention
Mercy Medical Center
~200 participants
Updated 2024-11-19 on ClinicalTrials.gov
What's tested:Heplisav-B Injectable Product, 2-dose regimenHeplisav-B Injectable Product, 3-dose regimen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The rates of seroconversion after two doses of Heplisav-B given at 0 and 4 weeks versus three doses of Heplisav-B given at 0, 4 weeks, and 8 weeks.
Measured over 12 weeks after completing Heplisav-B series with two doses or three doses

Conditions

Hepatitis B
Cirrhosis, Liver
Chronic Liver Disease

Explore related trials

CirrhosisHepatitis B Virus Surface Antibody

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Paul Thuluvath, MD · PRINCIPAL_INVESTIGATOR · Mercy Medical Center

Who to contact

CHAU TO, MD
[email protected]
(714)-400-1331
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • The rates of seroconversion after two doses of Heplisav-B given at 0 and 4 weeks versus three doses of Heplisav-B given at 0, 4 weeks, and 8 weeks.12 weeks after completing Heplisav-B series with two doses or three doses

    The rates of seroconversion is defined as an HBsAg antibody concentration ≥ 10 mIU/ml.