Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Post-vaccination serological response
研究概览
简要总结
The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml) after three intramuscular doses of 40 µg.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
- •Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
- •Patients over 18 years old.
- •Negative pregnancy test.
- •Patients who have given their consent to participate in the study.
排除标准
- •Absolute contraindication to HBV vaccine.
- •Medical history of allergy to any component of the vaccine.
- •Chronic renal failure on hemodialysis.
- •Presence of antibodies against Human Immunodeficiency Virus.
- •Patients with seroconversion (anti-HBs > 10 IU /ml) after the first three doses of vaccine.
- •Lack of consent to participate in the study.
研究组 & 干预措施
Single dose of HBV vaccine
Single dose (40µg) of HBV vaccine will be administered at 6 months after 1 cycle of HBV vaccination
干预措施: HBV vaccine (Biological)
Second HBV vaccination cycle
Second cycle of HBV vaccination (0, 1 and 2 months)will be administered. Three intramuscular doses of 40 µg.
干预措施: HBV vaccine (Biological)
结局指标
主要结局
Post-vaccination serological response
时间窗: At 35 ± 5 days after administration
To compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs \< 10 IU/ml) after three intramuscular doses of 40 µg at 0, 1 and 2 months.
次要结局
- Association of serological response to HBV vaccination to etiology and severity of cirrhosis(After 6 months)
- Association of serological response to HBV vaccination to body mass index(At baseline)
- Association of serological response to HBV vaccination to diabetes presence(After 6 months)
- Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence(At baseline)
- Association of serological response to HBV vaccination to obesity(After 6 months)