Liver Cirrhosis
Conditions
Brief 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.
Interventions
None listed
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis. | Day 0 |
Secondary
| 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 |
Countries
India
Contacts
CONTACTDr Vaishnavi S Kaza, MD
CONTACTDr Vikram Bhatia, DM
Outcome results
None listed