About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
>18 years of age with cirrhosis.
Anti-HAV IgG negative at screening.
No prior HAV vaccination.
Disqualifiers
Unable/unwilling to consent.
Pregnant patients.
Clinically unstable.
Trial population
Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
Secondary outcomes
Seroprevalence of IgG HAV stratified by Child-Pugh class (A/B/C).
Seroprevalence of IgG HAV stratified by MELD categories (<10, 10- 15, >15).
Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).
Seroprevalence of IgG HAV stratified by etiology.
Sponsors and contacts
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