EUCTR2012-005575-13-BE进行中（未招募）不适用
Prophylactic vaccination with autologous dendritic cells against human cytomegalovirus: a pilot study in patients awaiting kidney transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults awaiting kidney transplantation
- •Age: = 18 years
- •CMV-seronegative, defined as both IgG and IgM = 0
- •Negative CMV screening
- •Written informed consent
- •Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Difficult venous access
- •Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
- •Patients receiving medication (or other treatment) with an immunomodulating effect in a period of 100 days before the first DC vaccination and during the first year after the first DC vaccination. This includes oral, nasal or inhaled corticosteroids. Topical steroids are permitted but not on the vaccination site. Other vaccinations are not permitted, except for influenza vaccination.
- •History or evidence of autoimmune disease
- •Impaired immune responsiveness (of any cause) eg. genetic syndromes, hypoglobuli-nemias, chemotherapy in the last 3 months
- •HIV-seropositive patients
- •Any clinical laboratory abnormality deemed by the investigator to indicate significant undiagnosed illness
- •History or evidence of a physician-diagnosed chronic of recurrent inflammatory skin disease at the proposed site(s) of vaccination or DTH skin test in the past 5 years
- •Any evidence of damaged skin, moles, scars, tattoos or marks at the proposed actua-tion site(s) that might interfere with the interpretation of local skin reactions
- •Patients who received blood products (except albumin) in the previous 60 days
- •Patients awaiting multiple organ transplantation
研究者
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