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: 8.1 Level
Conditions
Interventions
Trade Name: Leucomax
Product Name: Leukomax
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Dutch Kidney Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -patients who previously received a bone marrow transplantation -patients with an auto-immune disease -patients with malignancies -pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does GM-CSF affect the development of HBsAg-specific T cells following HBV vaccination and result in reaching an adequate level of protection in non-responders to standard HBV vaccination?;Secondary Objective: ;Primary end point(s): Obtaining an adequate level of protection following HBV vaccination in haemodialysis patients who did not respond to standard HBV vaccination | — |
Countries
Netherlands
Outcome results
None listed