Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
February 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 19, 2024
March 1, 2024
1 year
February 10, 2024
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-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
At 7 months after complete vaccine administration
Secondary Outcomes (5)
Post-vaccination serological response
At 30 days after first dose administration
Post-vaccination serological response
At 1 year after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 1
At 30 days after first dose administration
Anti-hepatitis A Virus (HAV) antibody at month 7
At 7 months after complete vaccine administration
Anti-hepatitis A Virus (HAV) antibody at 1 year
At 1 year after first dose administration
Study Arms (2)
Intensive 3 dose
EXPERIMENTALReceiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6.
Standard 2 dose
ACTIVE COMPARATORReceiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Siriraj Hospital
Bangkok Noi, Bangkok, 10700, Thailand
Related Publications (8)
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.
PMID: 16708058RESULTKeeffe 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.
PMID: 7847285RESULTWebb 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.
PMID: 33110280RESULTLemon 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.
PMID: 28887164RESULTNoor 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.
PMID: 28507927RESULTArguedas 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.
PMID: 11855555RESULTWigg 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.
PMID: 30144521RESULTIoannou 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.
PMID: 33303216RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Watcharasak Chotiyaputta, Asso Prof
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, Faculty of Medicine, Siriraj Hospital
Study Record Dates
First Submitted
February 10, 2024
First Posted
February 26, 2024
Study Start
February 29, 2024
Primary Completion
March 1, 2025
Study Completion
May 31, 2025
Last Updated
March 19, 2024
Record last verified: 2024-03