Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06277882
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-10
Brief Title:
Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis A Randomized-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None