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Vaccine

Heplisav-B Injectable Product, 3-dose regimen for Hepatitis B

Phase 4

Recruiting

Led By Paul Thuluvath, MD

Research Sponsored by Mercy Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing if the hepatitis B vaccine is more effective when given in two doses or three doses for people with cirrhosis.

Who is the study for?

This trial is for adults over 18 with cirrhosis who visit Mercy Medical Center's hepatology clinic and lack immunity to Hepatitis B. It excludes those allergic to the hepatitis B vaccine or its components, yeast, previous hepatitis B exposure, post liver transplant patients, and anyone under 18.Check my eligibility

What is being tested?

The study aims to compare how well two different dosing schedules of Heplisav B (a hepatitis B vaccine) work in patients with cirrhosis. One group will receive a two-dose regimen while another will get three doses to see which provides better protection.See study design

What are the potential side effects?

Possible side effects from Heplisav B may include pain at the injection site, fatigue, headache, irritability in infants and toddlers after vaccination; serious allergic reactions are rare but can occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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.

Secondary outcome measures

Factors are associated with a lower likelihood of achieving immunogenicity, such as age, race, MELD scores, etiologies of cirrhosis, comorbidity, immunosuppressive drugs. Those information will be measured or described descriptively by chart review.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Non cirrhosis, 3-dose regimenExperimental Treatment1 Intervention

Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.

Group II: Cirrhosis, 3-dose regimenExperimental Treatment1 Intervention

Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.

Group III: Cirrhosis, 2-dose regimenActive Control1 Intervention

Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.

Group IV: Non cirrhosis, 2-dose regimenActive Control1 Intervention

Investigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mercy Medical CenterLead Sponsor

20 Previous Clinical Trials

4,022 Total Patients Enrolled

Paul Thuluvath, MD4.712 ReviewsPrincipal Investigator - Mercy Medical Center

Mercy Medical Center

1 Previous Clinical Trials

151 Total Patients Enrolled

5Patient Review

I would recommend Dr. Thuluvath to anyone seeking a trustworthy, competent physician. He is kind and takes the time to ensure his patients understand their conditions and treatment options.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies still available for those interested in participating in this clinical trial?

"As per the specifications on clinicaltrials.gov, this medical trial is actively recruiting participants with its initial posting occurring on September 14th 2020 and latest update taking place August 24th 2022."

Answered by AI

What is the overall participant count for this clinical trial?

"Affirmative. The clinical trial is presently accepting applications, as indicated by the information posted on clinicaltrials.gov. This medical study was initially published on September 14th 2020 and has been updated recently on August 24th 2022; it requires 200 participants from a single site in order to be completed successfully."

Answered by AI

To what degree does Heplisav-B Injectable Product, 3-dose regimen pose a threat to individuals?

"Data supports the safety of Heplisav-B Injectable Product, 3-dose regimen which has been given a score of 3. This Phase 4 trial indicates that this intervention is approved and ready for use."

Answered by AI