Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis

March 18, 2024 updated by: Watcharasak Chotiyaputta, Mahidol University

Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis: A Randomized-controlled Trial

The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.

However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population

HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.

The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.

The main questions it aims to answer are:

  • Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
  • Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine, Siriraj Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed advance fibrosis (F3) or cirrhotic (F4) status (radiologic finding or liver stiffness measurement or pathological report)
  • Negative anti-HAV IgM, IgG at baseline

Exclusion Criteria:

  • Positive anti-HAV IgG at baseline
  • Autoimmune hepatitis
  • Current hepatocellular carcinoma
  • Active other malignancies
  • Presence of antibodies against Human Immunodeficiency Virus
  • Received immunosuppressive drugs
  • Pregnancy or lactation
  • Decompensated cirrhosis with MELD ≥ 15
  • Chronic illness or bedridden patient who cannot travel to hospital
  • Lack of consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive 3 dose
Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.
Biological: HAVRIX
intramuscular injections
Other Names:
  • HAV vaccine
Active Comparator: Standard 2 dose
Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.
Biological: HAVRIX
intramuscular injections
Other Names:
  • HAV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-vaccination serological response rate
Time Frame: At 7 months after complete vaccine administration

To compare the seroconversion response rate at month 7

Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
At 7 months after complete vaccine administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-vaccination serological response
Time Frame: At 30 days after first dose administration

To compare the seroconversion response rate at month 1

Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
At 30 days after first dose administration
Post-vaccination serological response
Time Frame: At 1 year after first dose administration

To compare the seroconversion response rate at 1 year

Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
At 1 year after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 1
Time Frame: At 30 days after first dose administration
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
At 30 days after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 7
Time Frame: At 7 months after complete vaccine administration
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
At 7 months after complete vaccine administration
Anti-hepatitis A Virus (HAV) antibody at 1 year
Time Frame: At 1 year after first dose administration
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
At 1 year after first dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Watcharasak Chotiyaputta, Asso Prof, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 067/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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