Comparison of Seroconversion Rates Between Two-dose and Three-dose Regimens of Heplisav-B in Patients With Cirrhosis: A Randomized-Control Prospective Study

What this Trial Is About

Researchers are evaluating and comparing the immune response rates between two-dose and three-dose regimens of the hepatitis B vaccine Heplisav-B among patients with cirrhosis and chronic liver disease. This randomized prospective study aims to improve protection against hepatitis B, a major cause of liver disease, by assessing which vaccine schedule better induces immunity in this population. The study is sponsored by Mercy Medical Center and focuses on patients who lack existing hepatitis B immunity. Participants will be randomly assigned to receive either a two-dose Heplisav-B regimen at 0 and 4 weeks or a three-dose regimen at 0, 4, and 8 weeks. Patients will be grouped based on the presence or absence of cirrhosis and prior vaccine experience. The hepatitis B surface antibody levels will be measured 8 to 12 weeks after completing the vaccination series to classify participants as good responders, poor responders, or nonresponders. During the study, basic patient information including age, liver disease severity, causes of cirrhosis, and other health conditions will be collected. Researchers will monitor antibody levels to determine seroconversion rates, defined as antibody levels of 10 mIU/ml or higher. Data will be securely stored and analyzed. The main outcome is the rate of immunity achieved 12 weeks after vaccination. The study plans to enroll about 200 patients and will continue through December 2028.

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