Recruiting

Heplisav B vs. Heplisav B

Sponsor:

Mercy Medical Center

Code:

NCT04588077

Conditions

Hepatitis B

Cirrhosis, Liver

Chronic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heplisav-B Injectable Product, 2-dose regimen

Heplisav-B Injectable Product, 3-dose regimen

Study Details

Brief 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.

Conditions

Hepatitis B

Cirrhosis, Liver

Chronic Liver Disease

Study ID

NCT04588077

Start date

Sep 14, 2020

Status verified date

Nov, 2024

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cirrhosis, 3-dose regimen

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

active comparator: Cirrhosis, 2-dose regimen

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

experimental: Non cirrhosis, 3-dose regimen

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

active comparator: Non cirrhosis, 2-dose regimen

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

Interventions

Heplisav-B Injectable Product, 2-dose regimen

Investigators will randomly assign patients into a 2-dose regimen.

Heplisav-B Injectable Product, 3-dose regimen

Investigators will randomly assign patients into a 3-dose regimen.

Primary outcome measure

  • 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. [ Time Frame: 12 weeks after completing Heplisav-B series with two doses or three doses ]

Central Contacts and Locations

Central contacts

CHAU TO, MD

(714)-400-1331cto@mdmercy.com

Paul Thuluvath, MD

(410)-332-9308pthuluv@mdmercy.com

Locations

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

CHAU TO, MD

714-400-1331cto@mdmercy.com

PAUL THULUVATH, MD

(410)-332-9308pthuluv@mdmercy.com

More Information

Sponsor

Mercy Medical Center

Last update posted

Nov 19, 2024

Last verified

Nov, 2024

Keywords

  • hepatitis B vaccine
  • Heplisav-B
  • cirrhosis
  • chronic liver disease
  • 2 dose regimen
  • 3 dose regimen
  • non responder
  • poor responder
  • no response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Medical Center on 2024-11-19.