Clinical trial NCT06277882: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis
Official title: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cirrhosis
Hep A
Vaccination
Keywords: Cirrhosis
HAV
Hepatitis A
HAV vaccine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-vaccination serological response rate
timeFrame: At 7 months after complete vaccine administration
Secondary outcomes:
measure: Post-vaccination serological response
timeFrame: At 30 days after first dose administration
measure: Post-vaccination serological response
timeFrame: At 1 year after first dose administration
measure: Anti-hepatitis A Virus (HAV) antibody at month 1
timeFrame: At 30 days after first dose administration
measure: Anti-hepatitis A Virus (HAV) antibody at month 7
timeFrame: At 7 months after complete vaccine administration
measure: Anti-hepatitis A Virus (HAV) antibody at 1 year
timeFrame: At 1 year after first dose administration
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Watcharasak Chotiyaputta, Asso Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Advisory Committee on Immunization Practices (ACIP); Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006 May 19;55(RR-7):1-23.
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citation: Ioannou GN. HCC surveillance after SVR in patients with F3/F4 fibrosis. J Hepatol. 2021 Feb;74(2):458-465. doi: 10.1016/j.jhep.2020.10.016. Epub 2020 Dec 7.