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

NCT07433881 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Observational

Started

2026-02-25

Last updated

2026-02-25

Condition(s) studied

Liver Cirrhosis

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis. — Day 0

Trial sites (1)

Facility	City	Region	Status
Institute of Liver and Biliary Sciences	New Delhi	National Capital Territory of Delhi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07433881 on ClinicalTrials.gov ↗ ← All trials in India