Evaluating hepatitis A vaccination effectiveness in patients with advanced liver disease
Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis: A Randomized-controlled Trial
This study is testing if the standard two-dose hepatitis A vaccine is safe and effective for adults with advanced liver disease who haven't been exposed to hepatitis A before.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Trial ID | NCT06277882 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of the standard two-dose hepatitis A vaccination regimen in patients with advanced fibrosis or cirrhosis. It focuses on individuals aged 18 and older who have confirmed liver disease but are negative for hepatitis A antibodies. The study will compare the immune response and safety profile of the vaccine in this high-risk population, who may have compromised immune responses. By understanding the vaccine's effectiveness in these patients, the trial seeks to improve preventive measures against hepatitis A infection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed advanced fibrosis or cirrhosis and no prior hepatitis A infection.
Not a fit: Patients with a history of hepatitis A infection, autoimmune hepatitis, or those with decompensated cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve health outcomes for patients with advanced liver disease.
How similar studies have performed: While there is existing literature on hepatitis A vaccination in general populations, this specific focus on patients with advanced liver disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok Noi, Bangkok
- Faculty of Medicine, Siriraj Hospital — Bangkok Noi, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Watcharasak Chotiyaputta, Asso Prof — Mahidol University
- Study coordinator: Watcharasak Chotiyaputta, Asso Prof
- Email: watcharasak.cho@mahidol.ac.th
- Phone: 6624197281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.