Cirrhosis, Hep A, Vaccination
Conditions
Keywords
Cirrhosis, HAV, Hepatitis A, HAV vaccine
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.
Interventions
BIOLOGICALHAVRIX
intramuscular injections
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Post-vaccination serological response | At 30 days after first dose administration | To compare the seroconversion response rate at month 1 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 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 |
| 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 |
Countries
Thailand
Contacts
Primary ContactWatcharasak Chotiyaputta, Asso Prof
Backup ContactTawesak Tanwandee, Prof
Outcome results
None listed