Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2020
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
November 19, 2024
November 1, 2024
8.2 years
September 18, 2020
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
The rates of seroconversion is defined as an HBsAg antibody concentration ≥ 10 mIU/ml.
12 weeks after completing Heplisav-B series with two doses or three doses
Secondary Outcomes (1)
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.
Through study completion, an average of 1 year
Study Arms (4)
Cirrhosis, 3-dose regimen
EXPERIMENTALInvestigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.
Cirrhosis, 2-dose regimen
ACTIVE COMPARATORInvestigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.
Non cirrhosis, 3-dose regimen
EXPERIMENTALInvestigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.
Non cirrhosis, 2-dose regimen
ACTIVE COMPARATORInvestigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.
Interventions
Investigators will randomly assign patients into a 2-dose regimen.
Investigators will randomly assign patients into a 3-dose regimen.
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Related Publications (6)
A two-dose hepatitis B vaccine for adults (Heplisav-B). Med Lett Drugs Ther. 2018 Jan 29;60(1539):17-18. No abstract available.
PMID: 29364196RESULTRoni DA, Pathapati RM, Kumar AS, Nihal L, Sridhar K, Tumkur Rajashekar S. Safety and efficacy of hepatitis B vaccination in cirrhosis of liver. Adv Virol. 2013;2013:196704. doi: 10.1155/2013/196704. Epub 2013 Jun 6.
PMID: 23840211RESULTJackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
PMID: 29289383RESULTYanny B, Konyn P, Najarian LM, Mitry A, Saab S. Management Approaches to Hepatitis B Virus Vaccination Nonresponse. Gastroenterol Hepatol (N Y). 2019 Feb;15(2):93-99.
PMID: 31011303RESULTShetty A, Jun Yum J, Saab S. The Gastroenterologist's Guide to Preventive Management of Compensated Cirrhosis. Gastroenterol Hepatol (N Y). 2019 Aug;15(8):423-430.
PMID: 31592079RESULTAmjad W, Alukal J, Zhang T, Maheshwari A, Thuluvath PJ. Two-Dose Hepatitis B Vaccine (Heplisav-B) Results in Better Seroconversion Than Three-Dose Vaccine (Engerix-B) in Chronic Liver Disease. Dig Dis Sci. 2021 Jun;66(6):2101-2106. doi: 10.1007/s10620-020-06437-6. Epub 2020 Jul 2.
PMID: 32617767RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Thuluvath, MD
Mercy Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2020
First Posted
October 19, 2020
Study Start
September 14, 2020
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share