Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis

Launched by MAHIDOL UNIVERSITY · Feb 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to vaccinate patients who have advanced liver disease, specifically those with advanced fibrosis or cirrhosis, against hepatitis A virus (HAV). The researchers want to find out if giving a more intensive vaccination schedule (three doses instead of two) is more effective at protecting these patients from HAV, which can cause serious health issues in people with weakened livers. This study aims to see how well each vaccination schedule helps patients build up antibodies against the virus.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with advanced fibrosis or cirrhosis. They also need to be free of any hepatitis A antibodies before starting the study. Participants will receive either the standard two-dose vaccine or the intensive three-dose vaccine and will be monitored for their response to the vaccine. It’s important to know that patients with certain other health issues or conditions, such as active cancers or severe liver problems, will not be eligible for this study. Overall, this trial aims to improve vaccination strategies for high-risk patients to ensure they are better protected against hepatitis A.

Gender

ALL

Eligibility 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