A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The measures of immunogenicity, as determined by HI; MN and SRH
研究概览
简要总结
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.
详细描述
The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.
Uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.
Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.
Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Age > 18 .
- •Chronic dialysis for ESRD .
- •Life expectancy of at least 6 months.
排除标准
- •They have any serious disease
- •They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
- •They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- •Within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°C).
- •They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
研究组 & 干预措施
H1N1sw monovalent vaccine
干预措施: MF59 adjuvanted H1N1 influenza monovalent vaccine (Biological)
Thymosin alpha 1 3.2mg
干预措施: Thymosin alpha 1 (Drug)
Thymosin alpha 1 6.4 mg
干预措施: Thymosin alpha 1 (Drug)
结局指标
主要结局
The measures of immunogenicity, as determined by HI; MN and SRH
时间窗: Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course
次要结局
未报告次要终点