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 Type
OBSERVATIONAL
Enrollment
360
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
Time frame: Day 0
Seroprevalence of IgG HAV stratified by Child-Pugh class (A/B/C).
Time frame: Day 0
Seroprevalence of IgG HAV stratified by MELD categories (<10, 10- 15, >15).
Time frame: Day 0
Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).
Time frame: Day 0
Seroprevalence of IgG HAV stratified by etiology.
Time frame: 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
Time frame: day 28-35
Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.
Time frame: day 28-35
Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).
Time frame: Week 24
Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).
Time frame: day 28-35
AE/SAE after HAV vaccination.
Time frame: day 28-35
Decompensation events.
Time frame: day 28-35
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