Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis
1 other identifier
observational
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 27, 2027
February 25, 2026
February 1, 2026
1 year
February 19, 2026
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
Day 0
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
Liver Cirrhosis
Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
Eligibility Criteria
Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
You may qualify if:
- \>18 years of age with cirrhosis.
- Anti-HAV IgG negative at screening.
- No prior HAV vaccination.
You may not qualify if:
- Unable/unwilling to consent.
- Pregnant patients.
- Clinically unstable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 25, 2026
Study Start
February 25, 2026
Primary Completion (Estimated)
February 27, 2027
Study Completion (Estimated)
February 27, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02