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NCT Number: NCT07433881

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location contact

Dr Vaishnavi Kaza, MD

CONTACT

[email protected]

01146300000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  5. 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

  6. Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.

    Time frame: day 28-35

  7. Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).

    Time frame: Week 24

  8. Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).

    Time frame: day 28-35

  9. AE/SAE after HAV vaccination.

    Time frame: day 28-35

  10. Decompensation events.

    Time frame: day 28-35

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Vaishnavi S Kaza, MD

CONTACT

[email protected]

01146300000

Dr Vikram Bhatia, DM

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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