- To compare the course and determinants of the SARS-CoV-2-specific humoral and cellular immune response in AID patients upon primary SARS-CoV-2 infection to that in healthy controls (HC)- To determine the seroconversion rate, magnitude and…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
- Viral infectious disorders
Synonym
Health condition
hematologische en andere B-cel gemedieerde aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Effects of systemic immunosuppressive medication on the serologic response at
28-days after the second SARS-CoV-2 vaccination
• Difference in SARS-CoV-2-specific B- and T-cell frequencies and functional
phe-notype 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.
• Change in disease activity and/or relapses of underlying autoimmune disorders
• 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
• Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on serological
and cellular responses in immune-suppressed patients
• Effects of a second booster SARS-CoV-2 vaccine (third vaccine) on adverse
events within 7 days after vaccination, and changes in activity of underlying
auto- immune disorders within 8 weeks 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 patients with auto-immune disease (AID), including
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
AID patients 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 AID patients is critical to
tailor care and guidelines to maximally protect this vulnerable population.
Study objective
- To compare the course and determinants of the SARS-CoV-2-specific humoral and
cellular immune response in AID patients upon primary SARS-CoV-2 infection to
that in healthy controls (HC)
- To determine the seroconversion rate, magnitude and determinants of
SARS-CoV-2-specific immunity after vaccination in AID patients with and without
previous SARS-CoV-2 infection patients and compare to that in healthy persons
with and without previous SARS-CoV-2 infection.
Study design
This is a prospective observational cohort study consisting of two phases:
phase 1 starting during the pandemic up to start of phase 2 and phase 2
starting just prior to the national vac-cination campaign against SARS-CoV-2.
Study burden and risks
Participation in this study has negligible risk because the only intervention
done is fingerprick or venapuncture to obtain blood. In principal, study visits
will be primarily home-based and hospital visits are restricted and
preferentially planned to coincide with standard clinical visits to decrease
the burden for participants. There is no direct benefit for participants.
Results from this project will help to increase knowledge on immunity, both
after a SARS-CoV-2 infection and after vaccination, in immunosuppressed
patients. This study can only be done in this population.
Meibergdreef 9
Amsterdam 1108AZ
NL
Meibergdreef 9
Amsterdam 1108AZ
NL
Listed location countries
Age
Inclusion criteria
fase 1: auto-immune disease, treatment with at least one immunosuppressive
medication, SARS-CoV-2 infection
fase 2/group 1:auto-immune disease
fase 2/group 2: healthy control
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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74974.018.20 |
| OMON | NL-OMON23600 |