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

Phase 4

Recruiting

• Conditions: Hep A; Vaccination; Cirrhosis
• Interventions: Biological: HAVRIX

• Registration Number: NCT06277882
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-10
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-26
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard 2 dose	HAVRIX	Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.
Intensive 3 dose	HAVRIX	Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.

Primary Outcome Measures

Name	Time	Method
Post-vaccination serological response rate	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

Secondary Outcome Measures

Name	Time	Method
Anti-hepatitis A Virus (HAV) antibody at month 7	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
Post-vaccination serological response	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
Anti-hepatitis A Virus (HAV) antibody at month 1	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
Anti-hepatitis A Virus (HAV) antibody at 1 year	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

Trial Locations

Locations (1)

Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand