The main hypothesis is that specific mechanisms of action and level of immunosuppressive medication is the most important determinant of SARS-CoV-2 immunity after vaccination or infection in ISP patients.
ID
Bron
Verkorte titel
Aandoening
- Auto-immuunziekten
Aandoening
SARS-CoV-2, auto-immune diseases,
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Effects of systemic immunosuppressive medication on the serologic response at 28-days after the last SARS-CoV-2 vaccination - Difference in SARS-CoV-2-specific B- and T-cell frequencies and functional phenotype and determinants thereof
Achtergrond van het onderzoek
A better understanding of the maintenance of SARS-CoV-2-specific immunity after primo-infection (SIAP) is pertinent to address the risk of re-infection over time, especially for immune-suppressed patients (ISP) which may be at greater risk. In addition to this, there is uncertainty about the efficacy of the much-awaited vaccines in ISP compared to healthy individuals as it is known for other vaccines that protection is attenuated. A better of understanding of SIAP and the effects of induced immunity by vaccination in ISP is critical to tailor care and guidelines to maximally protect this vulnerable population.
Doel van het onderzoek
The main hypothesis is that specific mechanisms of action and level of immunosuppressive medication is the most important determinant of SARS-CoV-2 immunity after vaccination or infection in ISP patients.
Onderzoeksopzet
serology group: baseline (prior to vaccination); 28 days after first vaccination; 28 days after second vaccination; 12 months after first vaccination cellular group: baseline (prior to vaccination); 10 days after second vaccination;28 days after first vaccination; at second vaccination; 10 days after second vaccination; 28 days after second vaccination; 12 months after first vaccination
Algemeen / deelnemers
Wetenschappers
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with auto-immune disorders with or without immunosuppressive medication or healthy controls, above 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Known pregnancy during study entry. Concomitant treatment with immunosuppressive medication (like chemotherapy) for cancer or organ-transplantation (including stem-cell transplantation).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8900 |
| CCMO | NL74974.018.20 |
| EudraCT | 2021-001102-30 |
| OMON | NL-OMON55289 |