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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Faculty of Medicine, Siriraj Hospital
RECRUITING
Bangkok Noi
Contact Information
Primary
Watcharasak Chotiyaputta, Asso Prof
watcharasak.cho@mahidol.ac.th
6624197281
Backup
Tawesak Tanwandee, Prof
tawesak@gmail.com
6624197282
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 50
Treatments
Experimental: Intensive 3 dose
Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.
Active_comparator: Standard 2 dose
Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.
Related Therapeutic Areas
Sponsors
Leads: Mahidol University

This content was sourced from clinicaltrials.gov