With this study, we want to gain insight in the SARS-CoV-2 specific immunity (T- and B-cell) of patients with congenital immune disorders. This will add to our knowledge on SARS-CoV-2 specific immunity, and on the immune capacity of the patients…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. SARS-CoV-2 specific T-cell immunity
2. SARS-CoV-2 neutralizing antibodies
3. SARS-CoV-2 response after vaccination
Secondary outcome
None
Background summary
Observational studies have shown that the risk of a severe course of COVID-19
is higher in patients with immune disorders of diverse causes. Nevertheless,
our own scarce experience shows that the patients with congenital immune
disorders that we treat on our outpatient clinic and who contracted COVID-19,
did not have such a severe course. These patients mostly have humoral immune
disorders, implicating that their T-cell immunity is sufficient in suppressing
SARS-CoV-2 replication. Moreover, their response against SARS-CoV-2 after
vaccination will be measured.
Study objective
With this study, we want to gain insight in the SARS-CoV-2 specific immunity
(T- and B-cell) of patients with congenital immune disorders. This will add to
our knowledge on SARS-CoV-2 specific immunity, and on the immune capacity of
the patients with congenital immune disorders. In addition, we will measure the
response against SARS-CoV-2 after vaccination.
Study design
This is a single center, case-control study in which SARS-CoV-2 specific
immunity in patients with congenital immune disorders will be compared to the
response in patients without immune disorders. The cases and controls will be
matched on age, sex, BMI and relevant comorbidities such as diabetes. The
controls are participants who participated in two other recently executed
studies in het LUMC: BEAT-COVID (NL73740.058.20) for hospitalized patients and
SARS-RESONSE (NL73740.058.20) for outpatient patients.
Study burden and risks
Group relatedness: Since we will measure the SARS-CoV-2 specific immune
response in patients with congenital immune disorders we cannot perform the
analysis in other patients.
Burden: we will only perform one venous puncture and collect 40mL of blood,
which is a minimal burden to the participant. To limit the time burden we will
do our best to combine the study appointment with the outpatient clinic
appointment
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- congenital immune disorder for with they are monitored at the Infectious
Diseases outpatient clinic of the LUMC
- PCR-confirmed COVID-19 in the past or present
Exclusion criteria
- received a covid-19 vaccination before start of the study, regardless of the
type of vaccine or vaccine manufacturer
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76388.058.20 |