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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive 3 dose | Experimental | Receiving the intensive 3-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, 1, and 6. |
|
| Standard 2 dose | Active Comparator | Receiving the standard 2-dose regimen of the Havrix hepatitis A vaccine, administered at months 0, and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAVRIX | Biological | intramuscular injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-vaccination serological response | To compare the seroconversion response rate at month 1 Subjects are considered as being seroconversion if they were initially seronegative and become seropositive | At 30 days after first dose administration |
| Post-vaccination serological response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Watcharasak Chotiyaputta, Asso Prof | Contact | 6624197281 | watcharasak.cho@mahidol.ac.th | |
| Tawesak Tanwandee, Prof | Contact | 6624197282 | tawesak@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Watcharasak Chotiyaputta, Asso Prof | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Siriraj Hospital | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16708058 | Result | 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. | |
| 7847285 | Result | 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. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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To compare the seroconversion response rate at 1 year Subjects are considered as being seroconversion if they were initially seronegative and become seropositive |
| At 1 year after first dose administration |
| Anti-hepatitis A Virus (HAV) antibody at month 1 | To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients | At 30 days after first dose administration |
| Anti-hepatitis A Virus (HAV) antibody at month 7 | To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients | At 7 months after complete vaccine administration |
| Anti-hepatitis A Virus (HAV) antibody at 1 year | To compare Anti-HAV IgG level obtained with two different vaccination schemes against HAV in advance fibrosis and cirrhotic patients | At 1 year after first dose administration |
| 33110280 | Result | 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. |
| 28887164 | Result | 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. |
| 28507927 | Result | 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. |
| 11855555 | Result | 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. |
| 30144521 | Result | 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. |
| 33303216 | Result | 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. |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |