Liver CirrhosisNCT07433881
Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 360 participants
- Where
- 1 siteIndia
- Study dates
- 25 Feb 2026to 27 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
Who may be able to join
- >18 years of age with cirrhosis.
- Anti-HAV IgG negative at screening.
- No prior HAV vaccination.
Who cannot join
- Unable/unwilling to consent.
- Pregnant patients.
- Clinically unstable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Vaishnavi Kaza, MD, 01146300000, vaishnavikaza@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver Cirrhosis | Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
Measured: Day 0
Secondary outcomes (10)
Seroprevalence of IgG HAV stratified by Child-Pugh class (A/B/C).
Measured: Day 0
Seroprevalence of IgG HAV stratified by MELD categories (<10, 10- 15, >15).
Measured: Day 0
Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).
Measured: Day 0
Seroprevalence of IgG HAV stratified by etiology.
Measured: 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
Measured: day 28-35
Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.
Measured: day 28-35
Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).
Measured: Week 24
Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).
Measured: day 28-35
AE/SAE after HAV vaccination.
Measured: day 28-35
Decompensation events.
Measured: day 28-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433881
- Sponsor's protocol ID
- ILBS-HAV-01
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.
- ClinicalTrials.gov ID
- NCT07433881
- Acronym / sponsor ID
- ILBS-HAV-01
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Cirrhosis | – | –Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
Key inclusion criteria (3 listed)
- >18 years of age with cirrhosis.
- Anti-HAV IgG negative at screening.
- No prior HAV vaccination.
Key exclusion criteria (3 listed)
- Unable/unwilling to consent.
- Pregnant patients.
- Clinically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
Time frame: Day 0
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Vaishnavi S Kaza, MD (01146300000, vaishnavikaza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.