Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis

Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.

Hepatitis A virus (HAV) superinfection in patients with cirrhosis can precipitate acute hepatic decompensation and significantly worsen outcomes. Although HAV exposure was historically universal in India, recent evidence shows declining natural immunity in adults, particularly in urban populations. Contemporary data on HAV seroprevalence and vaccine immunogenicity in Indian cirrhotics remain scarce. Updated evidence is necessary to inform national vaccination policy for chronic liver disease.

This study aims to estimate the prevalence of anti-HAV IgG among adults with cirrhosis and identify predictors of non-immunity. A secondary objective is to evaluate early immunogenicity and durability of a single dose of inactivated HAV vaccine in baseline non-immune patients.

This study will generate updated sero-epidemiological data and prospective evidence on single-dose HAV vaccine immunogenicity in Indian cirrhotics, providing essential guidance for HAV vaccination policies in cirrhosis.

STUDY DESIGN: Observational cross-sectional study with a nested prospective cohort.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Dr Vikram Bhatia, DM; Phone Number: 01146300000; Email: vikrambhatiadr@gmail.com
• Study Contact Backup: Name: Dr Vaishnavi S Kaza, MD; Phone Number: 01146300000; Email: vaishnavikaza@gmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Institute of liver and Biliary Sciences
      • Contact: Dr Vaishnavi Kaza, MD; Phone Number: 01146300000; Email: vaishnavikaza@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.

Description

Inclusion Criteria:

1. >18 years of age with cirrhosis.
2. Anti-HAV IgG negative at screening.
3. No prior HAV vaccination.

Exclusion Criteria:

1. Unable/unwilling to consent.
2. Pregnant patients.
3. Clinically unstable.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver Cirrhosis; Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Seroprevalence of IgG HAV stratified by Child-Pugh class (A/B/C).	Day 0
Seroprevalence of IgG HAV stratified by MELD categories (<10, 10- 15, >15).	Day 0
Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).	Day 0
Seroprevalence of IgG HAV stratified by etiology.	Day 0
Seroprotection at day 28-35 (proportion achieving assay-defined protective anti-HAV IgG threshold >20mIU/mL) among baseline non-immune, after a single dose of inactivated HAV vaccine	day 28-35
Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.	day 28-35
Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).	Week 24
Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).	day 28-35
AE/SAE after HAV vaccination.	day 28-35
Decompensation events.	day 28-35

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): February 27, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis
• Other Study ID Numbers: ILBS-HAV-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No