Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- tetanus seroconversion rate
研究概览
简要总结
Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rate in hemodialysis patients.
详细描述
Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to HBV vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on Td vaccine response rate in hemodialysis patients. In this randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (<0.1 International Unit [IU]/ml) were enrolled. These patients were randomized into two equal groups to receive one dose of intramuscular Td vaccine supplemented with either levamisole 100 mg or placebo daily, six days before and six days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being under regular hemodialysis for more than 3 months
- •unprotective baseline levels of antitetanus IgG
排除标准
- •tetanus diphtheria (Td) vaccination in past year
- •leukopenia (WBC<1500 cells/mcL)
- •immunosuppressive drug exposure in past 2 months
- •recent hospitalization or history of transfusion of blood products in the past 3 months.
研究组 & 干预措施
Levamisole
Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
干预措施: Levamisole (Drug)
Placebo
Two placebo tablets daily, six days before and six days after Td vaccination.
干预措施: Placebo (Drug)
结局指标
主要结局
tetanus seroconversion rate
时间窗: 1 month and 6 month post vaccination
次要结局
未报告次要终点
研究者
Mohammad mahdi Sagheb
Associate Professor of Medicine
Shiraz University of Medical Sciences
