Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis
NCT ID: NCT06277882
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2024-02-29
2025-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intensive 3 dose
Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.
HAVRIX
intramuscular injections
Standard 2 dose
Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.
HAVRIX
intramuscular injections
Interventions
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HAVRIX
intramuscular injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine, Siriraj Hospital
Principal Investigators
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Watcharasak Chotiyaputta, Asso Prof
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine, Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Keeffe EB. Is hepatitis A more severe in patients with chronic hepatitis B and other chronic liver diseases? Am J Gastroenterol. 1995 Feb;90(2):201-5.
Webb GW, Kelly S, Dalton HR. Hepatitis A and Hepatitis E: Clinical and Epidemiological Features, Diagnosis, Treatment, and Prevention. Clin Microbiol Newsl. 2020 Nov 1;42(21):171-179. doi: 10.1016/j.clinmicnews.2020.10.001. Epub 2020 Oct 22.
Lemon SM, Ott JJ, Van Damme P, Shouval D. Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention. J Hepatol. 2017 Sep 5:S0168-8278(17)32278-X. doi: 10.1016/j.jhep.2017.08.034. Online ahead of print.
Noor MT, Manoria P. Immune Dysfunction in Cirrhosis. J Clin Transl Hepatol. 2017 Mar 28;5(1):50-58. doi: 10.14218/JCTH.2016.00056. Epub 2017 Mar 10.
Arguedas MR, McGuire BM, Fallon MB. Implementation of vaccination in patients with cirrhosis. Dig Dis Sci. 2002 Feb;47(2):384-7. doi: 10.1023/a:1013734525348.
Wigg AJ, Wundke R, McCormick R, Muller KR, Ramachandran J, Narayana SK, Woodman RJ. Efficacy of High-Dose, Rapid, Hepatitis A and B Vaccination Schedules in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2019 May;17(6):1210-1212.e1. doi: 10.1016/j.cgh.2018.08.047. Epub 2018 Aug 23.
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.
Other Identifiers
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Si 067/2024
Identifier Type: -
Identifier Source: org_study_id
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