[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626303":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":39,"armGroups":40,"interventions":11,"overallOfficials":11,"centralContacts":43,"locations":52,"responsibleParty":69,"collaborators":11,"id":71,"slug":11,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":11,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.",null,"Day 0",[14,16,18,20,22,25,27,30,32,34],{"measure":15,"description":11,"timeFrame":12},"Seroprevalence of IgG HAV stratified by Child-Pugh class (A\u002FB\u002FC).",{"measure":17,"description":11,"timeFrame":12},"Seroprevalence of IgG HAV stratified by MELD categories (\u003C10, 10- 15, >15).",{"measure":19,"description":11,"timeFrame":12},"Seroprevalence of IgG HAV stratified by age bands (18-29, 30-44, 45-59, ≥60).",{"measure":21,"description":11,"timeFrame":12},"Seroprevalence of IgG HAV stratified by etiology.",{"measure":23,"description":11,"timeFrame":24},"Seroprotection at day 28-35 (proportion achieving assay-defined protective anti-HAV IgG threshold >20mIU\u002FmL) among baseline non-immune, after a single dose of inactivated HAV vaccine","day 28-35",{"measure":26,"description":11,"timeFrame":24},"Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.",{"measure":28,"description":11,"timeFrame":29},"Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).","Week 24",{"measure":31,"description":11,"timeFrame":24},"Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).",{"measure":33,"description":11,"timeFrame":24},"AE\u002FSAE after HAV vaccination.",{"measure":35,"description":11,"timeFrame":24},"Decompensation events.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":37,"timePerspective":38,"maskingInfo":11},"CASE_ONLY","CROSS_SECTIONAL","Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.",[41],{"label":42,"type":11,"description":39,"interventionNames":11},"Liver Cirrhosis",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Dr Vaishnavi S Kaza, MD","CONTACT","01146300000","vaishnavikaza@gmail.com",{"name":50,"role":46,"phone":47,"phoneExt":11,"email":51},"Dr Vikram Bhatia, DM","vikrambhatiadr@gmail.com",[53],{"facility":54,"status":11,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Institute of Liver and Biliary Sciences","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":61,"coordinates":62},"Point",[63,64],77.2148,28.62137,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":47,"phoneExt":11,"email":48},"Dr Vaishnavi Kaza, MD",{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100626303",false,"NCT07433881","Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis","Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.","Inclusion Criteria:\n\n1. \\>18 years of age with cirrhosis.\n2. Anti-HAV IgG negative at screening.\n3. No prior HAV vaccination.\n\nExclusion Criteria:\n\n1. Unable\u002Funwilling to consent.\n2. Pregnant patients.\n3. Clinically unstable.","ALL","18 Years",{"count":80,"type":81},360,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nThis 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.\n\nSTUDY DESIGN: Observational cross-sectional study with a nested prospective cohort.",[42],"NOT_YET_RECRUITING","2026-02-19",{"date":88,"type":89},"2026-02-25","ACTUAL",{"date":88,"type":81},{"date":92,"type":81},"2027-02-27",{"name":5,"class":6},1]