Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.
Overview
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.
Primary outcome measures
- Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis. [Time frame: Day 0]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- >18 years of age with cirrhosis.
- Anti-HAV IgG negative at screening.
- No prior HAV vaccination.
Exclusion criteria
- Unable/unwilling to consent.
- Pregnant patients.
- Clinically unstable.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
India · 1 center
- Institute of Liver and Biliary Sciences — New Delhi
Identifiers
NCT: NCT07433881 · ILBS-HAV-01