Impact of Hepatitis B Vaccination on HBsAg Kinetics, Interferon-inducible Protein 10 Level and Recurrence of Viremia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- production of protective HBsAb
研究概览
简要总结
- HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.
- HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC.
- There is an impaired immune response to HBsAg and HBV vaccine is an easily available, cost-effective, non-harmful method of stimulating immunity.
详细描述
Persistent HBs antigenemia >1000 IU/ml has a possibility of viral reactivation and hepatoma in 8%; the effect of HBV vaccine on HBsAg was investigated, recurrence of viremia, insulin resistance, and fibrosis regression.
From August 2011 to October 2016, 220 participants with chronic hepatitis B were evaluated at the hepatology clinic-Internal medicine department-Zagazig university-Egypt. They were enrolled after approval of the ethical committee of Zagazig university hospital. Written informed consent was obtained for the interview, clinical evaluation, and blood sampling.
participants were divided into two groups:
- Inactive carriers (n=100) who were presented with persistent HBsAg, undetected HBV DNA, normal liver enzymes, positive HBeAb and had never been exposed to antiviral therapy.
- Patients exposed to NAs (n=120): tenofovir 300mg (n=65) or Entecavir 1mg (n=55): A- HBeAg-positive patients (n=60) who received NAs until 1 year after HBe seroconversion and disappearance of HBV DNA with persistent HBsAg B- HBeAg-negative patients (n=60) who received NAs till 3 years after the disappearance of HBV DNA; all showed persistent HBsAg.
- Exclusion criteria Clinically decompensated liver cirrhosis; hepatocellular carcinoma; other causes of liver disease or mixed causes (excessive alcohol consumption, autoimmune liver disease, immunosuppressive drugs, or who had been infected with hepatitis C virus.
B- Vaccination schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
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
- 是
入选标准
- •HBV patients with persistent HBs antigenemia
排除标准
- •decompensated liver cirrhosis
- •hepatocellular carcinoma
- •other causes of liver disease or mixed causes (excessive alcohol consumption,
- •autoimmune liver disease
- •immunosuppressive drugs
- •infection with hepatitis C virus.
研究组 & 干预措施
control group
A control group (n=100) did not receive HBV vaccine
chronic HBV with persistent HBsAg
inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia.
they were given 30 µg of HBV vaccine initiated 6 months after HBe seroconversion and disappearance of HBV DNA.
干预措施: HBV vaccine (Biological)
结局指标
主要结局
production of protective HBsAb
时间窗: three months after the last dose of vaccine
Current treatment by NAs may suppress HBV replication but cannot completely eradicate the virus due to the systemic immune tolerance or exhaustion. HBV vaccine may enhance the immunity against HBsAg and may be an efficient immunotherapy in chronic HBV.
次要结局
- impact on Insulin resistance, fibrosis regression(3 month after the last dose of vaccination)
研究者
Amr Shaaban Hanafy
Assistant professor
Zagazig University