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临床试验/NCT00705692
NCT00705692已完成2 期

Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.

干预措施: Levamisole (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad mahdi Sagheb

Associate Professor of Medicine

Shiraz University of Medical Sciences

研究点 (1)

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