Open-Label, Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load
试验速览
- 阶段
- 3 期
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210
研究概览
简要总结
The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.
详细描述
HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with >90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for anti-HIV antibody
- •At least 18 years of age
- •CD4 > 200 cell/mm3
- •On antiretroviral therapy
- •Viral load < 50 copies/ml
- •Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)
- •No history of previous hepatitis B vaccination
- •Anti-HCV negative
- •No active opportunistic infection at the time of screening
- •Willing to sign informed consent
- •Able to follow up
排除标准
- •Pregnancy or breast feeding
- •History of hypersensitivity to any component of vaccine
- •Diagnosis of malignancy and receiving chemotherapy or radiation
- •Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
- •On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)
- •Renal failure (creatinine clearance < 30 mL/min)
- •Decompensated cirrhosis (child-pugh C)
- •Not able to follow up
结局指标
主要结局
Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210
时间窗: Day 210
1. To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) 2. To compare the seroconversion rate at day 210 of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients
次要结局
- Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year(1 year)
- Number of subjects with adverse events after vaccination(180 days)