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

Mahidol University

Status and phase: Enrolling; Phase 4

Conditions: Cirrhosis; Vaccination; Hep A

Treatments: Biological: HAVRIX

Study type: Interventional

Funder types: Other

Identifiers

NCT06277882

Si 067/2024

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intensive 3 dose

Experimental group

Description:

Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.

Treatment:

Biological: HAVRIX

Standard 2 dose

Active Comparator group

Description:

Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.

Treatment:

Biological: HAVRIX