Double-blind, placebo-controlled, randomized trial to compare antibody response to four standard- versus double-dose schedule of hepatitis B vaccine in pre-dialysis patients with eGFR<60 ml/min
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The proportion of patients who could achieve sero-protection, i.e. achieved anti-HBs titer ≥10 mIU per mL, following four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccine
研究概览
简要总结
Background: Chronic kidney disease (CKD) is staged as I, ≥ 90; II, 60-89; III, 30-59; IV, 15-29; V, <15 ml/min of eGR). Stage V patients require maintenance hemodialysis (MHD) and are vaccinated with four 2.0 ml doses (0, 1, 2 and 6 months) of hepatitis B vaccine. Standard vaccination schedule for healthy adults comprises of three 1.0 ml doses (0,1, and 6 months). In lack of data on vaccine efficacy in pre-dialysis population, same recommendation is practiced for pre-dialysis CKD patients also.
Novelty: This will be first randomized controlled trial, with adequate power and sample size, in pre-dialysis CKD patients.
Objective: To compare the seroconversion, seroprotection, and anti-HBs antibody titers obtained with 1.0 ml versus 2.0 ml four dose schedule in pre-dialysis patients
Methods: Adult (n=400) with eGFR between 60 and 15 ml per min, who are not on MHD, will be randomized in ‘Intervention arm’ (1.0 ml vaccine plus 1.0 ml placebo at 0, 1, 2, and 6 months) or ‘Control arm’ (2 x 1.0 ml vaccine at 0, 1, 2, and 6 months). Serum anti-HBs titer will be measured at 4, 8, 12-24, 28-36, and 48-64 weeks from the first dose of vaccine. Anti-HBs titre
10 mIU/mL at any time after four doses of vaccine will define seroprotection.
Expected outcomes: Results will compare the antibody response with standard or double dose of vaccine in pre-dialysis patients. It will help us to estimate the additional benefit obtained by using extra volume of vaccine in pre-dialysis population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •people with chronic kidney disease with estimated GFR between 60 and 15 ml per min
- •who are not on maintenance hemodialysis (MHD)
- •age between 19 and 65 years
- •are unlikely to need MHD in next 18 months
- •not received hepatitis B vaccination
- •HBsAg and anti-HBs antibody negative
- •body mass index (BMI) more than 18.5 Kg per M2.
排除标准
- •Hepatitis C virus or HIV coinfection
- •Post-organ transplant recipients
- •On immunosuppressive medication, regardless of indication
- •Presence of malignancy, regardless of its nature and stage of disease
- •Pregnant and lactating women.
结局指标
主要结局
The proportion of patients who could achieve sero-protection, i.e. achieved anti-HBs titer ≥10 mIU per mL, following four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccine
时间窗: 4-12 weeks after the administration of fourth dose of the vaccine
次要结局
- Compare the proportion of patients who could achieve sero-conversion (anti-HBs antibody detected) after four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccine(4-12 weeks after the administration of fourth dose of the vaccine)
- Compare the geometrical mean titer of anti-HBs antibody achieved after four standard or double doses of hepatitis B vaccine in those who could achieve seroprotection(4-12 weeks after the administration of fourth dose of the vaccine)
- Identify the risk factors associated with poor vaccine response (seroconversion, seroprotection)(4-12 weeks after the administration of fourth dose of the vaccine)
- Compare the qualitative and quantitative durability of vaccine induced antibody response (seroprotection as well as anti-HBs titer) at one year from the administration of first dose of the vaccine.(12 to 15 months after the administration of first dose of vaccine)
研究者
Amit Goel
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)