Effect of GM-CSF on development of antigen-specific T cell responses following hepatitis B vaccinatio
- Conditions
- Haemodialysis patients are susceptible for infections due to a continuous mildly activated immune system. About 40% of the haemodialysis patients does not respond to the standard HBV vaccination procedure by achieving an adequate level of protection (anti-HBs titer>100 IU/L), also named non-responders.Recently, a pilot study demonstrated an additive effect of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to eventually reaching an adequate protection level.MedDRA version: 8.1Level: LLTClassification code 10018487Term: GM-CSF prophylaxis
- Registration Number
- EUCTR2006-004674-27-NL
- Lead Sponsor
- Dutch Kidney Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-haemodialysis patients with a antibody titer for HBs below 10 IU/L following 4 injections with recombinant HBV vacccin
-patients should be on haemodialysis for at least 1 year
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
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-patients who previously received a bone marrow transplantation
-patients with an auto-immune disease
-patients with malignancies
-pregnant women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method