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
Source
Brief title
Condition
- Autoimmune disorders
Health condition
SARS-CoV-2, auto-immune diseases,
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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
Secondary outcome
- Changes in SARS-CoV-2 IgM, IgG and IgA responses over time and determinants thereof. - Speed of mounting, the magnitude and persistence of the immune response against SARS-CoV-2 and determinants thereof. - Number of confirmed SARS-CoV-2 (re-) infections and determinants thereof. - Clinical determinants (including age and gender, disease, disease mechanism and medication) of SIAP - Clinical determinants of patient choices and preferences related to vaccine administrations - Differences in IgG/IgM/IgA antibodies against different SARS-CoV-2 proteins over time - Change in disease activity and/or relapses of underlying autoimmune disorders within 8 weeks after SARS-CoV-2 infection and vaccination - Changes in and determinants of disease activity and/or relapses in the underlying AID during the study period - Incidence and determinations of short-term adverse events after vaccination - Differences in and determinants of severity of SARS-CoV-2 (re-) infections. - The number of ISP with SARS-CoV-2 IgM, IgG and IgA antibodies at baseline in patients with previously positive PCR. - Compare early SIAP development to immunity at follow-up and development of induced immunity after vaccination
Background summary
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.
Study objective
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.
Study design
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
Age
Inclusion criteria
Patients with auto-immune disorders with or without immunosuppressive medication or healthy controls, above 18 years
Exclusion criteria
Known pregnancy during study entry. Concomitant treatment with immunosuppressive medication (like chemotherapy) for cancer or organ-transplantation (including stem-cell transplantation).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8900 |
| CCMO | NL74974.018.20 |
| EudraCT | 2021-001102-30 |
| OMON | NL-OMON55289 |