E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hemodialysis patients hemodialysis patients with comorbidities |
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E.1.1.1 | Medical condition in easily understood language |
patients with renal failure requiring renal function replacement therapy (i.e. hemodialysis) patients with renal failure requiring renal function replacement therapy with other medical conditions |
patiënten met nierfalen die nierfunctievervangende therapie (d.i. hemodialyse) vereisen patiënten met nierfalen die nierfunctievervangende therapie met bijkomende aandoeningen |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
analysis of predictive factors (clinical and immunological) for the immune response in hemodialysis patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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 weeks (+/-3 days), 8 weeks (+/-3 days) and 24 weeks (+/-3 days) after vaccine administration. |
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E.5.2 | Secondary end point(s) |
identical to primary end point data collection |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
search for biomarkers predictive for efficacy in this target population |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
the trial follows the routine practice of COVID-vaccination, except for additional blood sampling |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
other pathology - hemodialysis vs comorbidity vs healthy controls |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |