Study of hepatitis B vaccination in adults with liver cirrhosis

Efficacy and Safety of Hepatitis B Vaccination in Adult Cirrhotic Patients of Non-HBV Etiology-A Randomized Control Study of Standard Dose Versus High Dose Vaccination - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110852

Enrollment

148

Registered

2026-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Double dose of Hepatitis B vaccination: Hepatitis B vaccination administered as double dose (40 ug intramuscular at 0,1,6 months schedule Control Intervention1: Single dose Hepatitis B

Eligibility

Inclusion criteria

Inclusion criteria: Age above 18 years, Patients who are diagnosed to have cirrhosis of liver in CTP A and B with Non HBV etiology, no H/O HBV vaccine

Exclusion criteria

Exclusion criteria: Child Pugh Score -C , Cirrhosis with Hepatocellular carcinoma , Any other coexisting Malignancy/Patients on chemotherapy, Immunosuppressive state and on immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame
Seroconversion rate in cirrhosis of non HBV etiologyTimepoint: 6 weeks after the last the last vaccine dose	—

Secondary

Measure	Time frame
Safety and efficacy of vaccineTimepoint: 6 weeks after the last dose of vaccine;Vaccine response based on cirrhosis gradingTimepoint: 6 weeks after the last dose of vaccine;Factors associated with non responseTimepoint: 6 weeks after the last dose of vaccine	—

Countries

India

Contacts

Public ContactRohith Lagisetti

Govind Ballabh Pant Institute of Post Graduate Medical Education and Research

usonika@gmail.con919718599252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026