The main objective of this study is to assess effectiveness of the COVID-19 vaccinations, based on humoral (anti-coronavirus antibody) immunity, in GCA and PMR patients. Other objectives are assessing antigen-specific cellular (T-cell) immune…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Viral infectious disorders
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of humoral (antibody) immune responses to the coronavirus vaccine
in GCA/PMR patients compared to the reference values and to matched healthy
controls.
Secondary outcome
Assessment of cellular (T-cell) immune responses to the coronavirus vaccine in
GCA/PMR patients
Documentation of vaccination side-effects
Background summary
Giant cell arteritis (GCA) and Polymyalgia Rheumatica (PMR) are overlapping
autoinflammatory diseases that occur exclusively in people older than 50. Both
diseases are treated with immunosuppressive drugs (glucocorticoids (GCs)), that
suppress disease activity, but leave patients at risk for serious infections.
Vaccination is thought to be the best way to prevent severe COVID-19 in these
patients, however, so far no studies have been performed to assess immune
responses after vaccination in GCA and PMR.
Study objective
The main objective of this study is to assess effectiveness of the COVID-19
vaccinations, based on humoral (anti-coronavirus antibody) immunity, in GCA and
PMR patients. Other objectives are assessing antigen-specific cellular (T-cell)
immune responses to the vaccine, the documentation of vaccination side-effects
and improving the understanding of immune responses after vaccination in GCA
and PMR patients.
Study design
This is a longitudinal, observational study to investigate immune responses to
vaccination. GCA/PMR patients will be asked to visit twice: pre-vaccination,
and post-vaccination (28 days later). Serum/plasma and PBMCs will be stored at
each visit.
Study burden and risks
As the vaccinations are part of the National vaccination programmes, the
vaccinations do not present an extra burden for the participants in this study.
The participants will be asked to visit the outpatient clinic twice:
pre-vaccination and post-vaccination. The first corona vaccinations are planned
spring 2021. If possible, the study visits will be combined with the scheduled
visits as part of their regular care. Pre- and post-vaccination, six 10mL blood
tubes will be drawn by venepuncture. In addition, questions will be asked with
regards to infections and vaccination side-effects.
Hanzeplein 1 1
Groningen 9713GZ
NL
Hanzeplein 1 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Give written informed consent
Diagnosed with GCA or PMR
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
Concomitant chronic diseases that may affect the immune system (such as prior
or current malignant disease, active infectious disease, other rheumatic
disease, kidney disease, active allergy etc.)
Severe anaemia defined as a hemoglobin of less than 6,0 g/dL
Confirmed SARS-CoV-2 infection (current or previous)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-001974-52-NL |
| CCMO | NL77489.042.21 |
| Other | NTR aangemeld |