hemodialysis patients hemodialysis patients with comorbidities
Conditions
Sponsors
AZ Sint-Jan Brugge-Oostende AV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consecutive series of hemodialysis patients receiving Covid-19 RNA vaccine. A target of at least 100 patients is envisioned. Minimum age for inclusion is 18 years. 2. at least thirty healthy volunteers receiving Covid-19 RNA vaccine. Minimum age for inclusion is 18 years. Individuals with immune disorders cannot participate. 3. at least thirty patients older than 50 years with at least 1 comorbidity (such as heart failure, diabetes, COPD, liver cirrhosis,....), but no chronic renal insufficiency. Minimum age for inclusion is 18 years. Only patients who receive vaccine on a voluntary basis will be included. 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 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - patients younger than 18 years old - patients who do not voluntarily ask for a COVID-vaccination - patients not eligible according to abovementioned inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this trial we aim to measure the humoral and immune response after vaccination with one of 2 types of COVID-19 vaccines, recently approved by the EMA for use in the European Union: the BNT162b2 mRNA COVID- 19 vaccine from BioNTec/Pfizer and the SARS-CoV-2 mRNA-1273 vaccine from Moderna. This in hemodialysis patients of 18 years and older, in comparison with patients with comorbidities and healthy volunteers. Blood sampling will be performed during dialysis via catheter or AV fistula. In the healthy volunteers and patients with comorbidities, blood will be drawn. Exact timing of blood draws will be point zero (day of vaccination to 1 week before vaccine administration), and 4 weeks (+/-3 days), 8 weeks (+/-3 days) and 24 weeks (+/-3 days) after vaccine administration. Patients will be recruited in Belgium in the following hospitals: AZ Sint- Jan Brugge-Oostende AV (coordinating site), Zuid-Oost Limburg, AZ Groeninge, OLV Aalst, and curando vzw.;Secondary Objective: analysis of predictive factors (clinical and immunological) for the immune response in hemodialysis patients;Primary end point(s): 1. Measurement of anti-S and anti-N antibodies. SARS-CoV-2 IgG against the S and N protein will be quantitatively measured by chemiluminescent microparticle immunoassay (Architect-I System by Abbott, Sligo, Ireland). 2. Measurement of interferon gamma production. Interferon production by SARS-CoV specific T cells will be measured using the QuantiFERON Sars-CoV-2 kit (Qiagen). 3. Baseline immune status (only in hemodialysis patients). Before vaccination the following parameters are determined: number of lymphocytes, number of CD4 positive lymphocytes, number of CD8 positive lymphocytes, number of CD19 positive lymphocytes, B and T cell memory subsets, protein electrophoresis, C3, C4, total IgG, IgA and IgM.;Timepoint(s) of evaluation of this end point: Time of blood sampling is point zero (day of vaccination to 1 week before vaccine administration), and 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): identical to primary end point data collection;Timepoint(s) of evaluation of this end point: identical to primary end point timepoints, namely Time of blood sampling is point zero (day of vaccination to 1 week before vaccine administration), and 4 weeks (+/-3 days), 8 weeks (+/-3 days) and 24 weeks (+/-3 days) after vaccine administration. | — |
Countries
Belgium
Contacts
Public ContactCTC
clinical trial center
Outcome results
None listed