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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
intramuscular injections
Faculty of Medicine, Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
RECRUITINGPost-vaccination serological response rate
To compare the seroconversion response rate at month 7 Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
Time frame: At 7 months after complete vaccine administration
Post-vaccination serological response
To compare the seroconversion response rate at month 1 Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
Time frame: At 30 days after first dose administration
Post-vaccination serological response
To compare the seroconversion response rate at 1 year Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
Time frame: At 1 year after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 1
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
Time frame: At 30 days after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 7
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
Time frame: At 7 months after complete vaccine administration
Anti-hepatitis A Virus (HAV) antibody at 1 year
To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients
Time frame: At 1 year after first dose administration
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