protocolSection identificationModule nctId: NCT06277882, orgStudyIdInfo id: Si 067/2024, briefTitle: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: 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 populationHAV 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., conditionsModule conditions: Cirrhosis, conditions: Hep A, conditions: Vaccination, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: HAVRIX, outcomesModule primaryOutcomes measure: Post-vaccination serological response rate, secondaryOutcomes measure: Post-vaccination serological response, secondaryOutcomes measure: Post-vaccination serological response, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at month 1, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at month 7, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at 1 year, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Siriraj Hospital, status: RECRUITING, city: Bangkok Noi, state: Bangkok, zip: 10700, country: Thailand, contacts name: Watcharasak Chotiyaputta, Asso Prof, role: CONTACT, phone: 6624197281, email: watcharasak.cho@mahidol.ac.th, geoPoint lat: 13.76266, lon: 100.47798, hasResults: False