Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

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 volunteers

Qualifiers

>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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

360 Participants
are grouped into 1 trial group
Group A: Liver Cirrhosis

Trial outcomes

Primary outcomes

1

Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.

Time frame
Day 0

Secondary outcomes

1

Seroprevalence of IgG HAV stratified by Child-Pugh class (A/B/C).

Time frame
Day 0
2

Seroprevalence of IgG HAV stratified by MELD categories (<10, 10- 15, >15).

Time frame
Day 0
3

Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).

Time frame
Day 0
4

Seroprevalence of IgG HAV stratified by etiology.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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