Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age with cirrhosis.
- •Anti-HAV IgG negative at screening.
- •No prior HAV vaccination.
排除标准
- •Unable/unwilling to consent.
- •Pregnant patients.
- •Clinically unstable.
研究组 & 干预措施
Liver Cirrhosis
Adult patients with cirrhosis attending outpatient clinics or admitted to ILBS, New Delhi.
结局指标
主要结局
Anti-HAV IgG seroprevalence (proportion positive) with 95% CI among patients with cirrhosis.
时间窗: Day 0
次要结局
- 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)
- Seroconversion at day 28-35 (negative-to-positive) after a single dose of inactivated HAV vaccine.(day 28-35)
- Seroprotection at week 24 after a single dose of inactivated HAV vaccine (indicating durability).(Week 24)
- Predictors of non-response to HAV vaccination (severity and etiology of liver disease, co-morbidities).(day 28-35)
- AE/SAE after HAV vaccination.(day 28-35)
- Decompensation events.(day 28-35)