Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis: A Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Post-vaccination serological response rate
研究概览
简要总结
The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.
However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population
HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.
The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.
The main questions it aims to answer are:
- Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
- Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Confirmed advance fibrosis (F3) or cirrhotic (F4) status (radiologic finding or liver stiffness measurement or pathological report)
- •Negative anti-HAV IgM, IgG at baseline
排除标准
- •Positive anti-HAV IgG at baseline
- •Autoimmune hepatitis
- •Current hepatocellular carcinoma
- •Active other malignancies
- •Presence of antibodies against Human Immunodeficiency Virus
- •Received immunosuppressive drugs
- •Pregnancy or lactation
- •Decompensated cirrhosis with MELD ≥ 15
- •Chronic illness or bedridden patient who cannot travel to hospital
- •Lack of consent to participate in the study
结局指标
主要结局
Post-vaccination serological response rate
时间窗: At 7 months after complete vaccine administration
To compare the seroconversion response rate at month 7 Subjects are considered as being seroconversion if they were initially seronegative and become seropositive
次要结局
- Anti-hepatitis A Virus (HAV) antibody at month 7(At 7 months after complete vaccine administration)
- Post-vaccination serological response(At 1 year after first dose administration)
- Anti-hepatitis A Virus (HAV) antibody at month 1(At 30 days after first dose administration)
- Anti-hepatitis A Virus (HAV) antibody at 1 year(At 1 year after first dose administration)
研究者
Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine, Siriraj Hospital
Mahidol University