Monitoring & evaluation of immune responses induced by COVID-19 vaccines in the general population in the Netherlands.
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
Synonym
Health condition
immuunsysteem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter of the study is COVID-19 vaccine (e.g. Spike
protein)-specific serum IgG (GMC) at day 28 after completion of COVID-19
vaccination, by multiplex immune assay (MIA).
Secondary outcome
a. Humoral, cellular and innate COVID-19 vaccine-induced immune responses
b. Virus neutralizing capacity of antibodies induced by COVID-19 vaccination
c. Fc functionality of antibodies (e.g. complement deposition) and antibody
glycosylation status induced by COVID-19 vaccination
d. COVID-19 vaccine-induced antibodies in nasal mucosal lining fluid
e. Reactogenicity self-reported in questionnaires shortly after vaccination
Background summary
Vaccination against SARS-CoV-2 is the most effective way to end the current
pandemic. However, it is currently unknown which level and type of immune
responses will be induced by COVID-19 vaccination in the Dutch general
population. This study aims to evaluate humoral, cellular and innate immune
responses induced by COVID-19 vaccines in generally healthy subjects in the
Netherlands. This includes neutralizing antibodies, associated with prevention
of infection by SARS-CoV-2, as well as other immune parameters that may govern
vaccine-induced protection against disease and transmission. Also, the study
will provide a comparison of immune responses in these healthy subjects with
responses in risk groups that are being assessed in other trials. Ultimately,
the study supports evidence-based vaccination strategies to reach and sustain
optimal population immunity.
Study objective
Monitoring & evaluation of immune responses induced by COVID-19 vaccines in the
general population in the Netherlands.
Study design
Longitudinal observational study.
Study burden and risks
The burden associated with participation involves collection of finger prick
blood samples by self-sampling at home for all participants (5 times max. 800
ul per finger prick). In a subset of participants, 3 of 5 finger pricks are
replaced by venapuncture blood collections (4 times; 32-89 mL per visit with a
max. total volume of 269 mL over 1 year), faeces collection (once) and nasal
mucosal lining fluid collection by nasosorption strips (3 times) during the
follow up of 1 year. In addition, all subjects will be asked to fill in
questionnaires at almost all timepoints. All participants will receive COVID-19
vaccination as part of the national immunization program provided by the Dutch
government, that they would have received regardless of this study. The
potential risks of sampling performed within the proposed study are considered
minimal. The benefit for the individual subjects in this trial is low. Results
of the study will support evidence-based optimisation of vaccination strategies
within the Dutch population. The amount of collected blood is lower in
children and age dependent.
In case of partcipation in the booster vaccination study additional blood will
be collected in up to four visits, with an additional max. total volume of 133
ml over 1 year in the subgroup; as well as
additional mucosal lining fluid collection by nasosorption strips at maximal 3
timepoints.
Participants in the general study are asked to perform a fingerpick by which an
additional ammount of 3.2 ml blood will be collected (4 timepoints in 1 year,
800 ul each time).
The amount of collected blood is lower in children and age dependent.
All participants are asked to complete a questionairre at timepoints B0-B3.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
• Be 0 - 60 years at the time of inclusion
• Be capacitated mentally and physically
• Be willing to receive SARS-CoV-2 vaccine
• Having signed the Informed Consent
Exclusion criteria
• Participation in a phase I/II/III vaccination trial where the subject will be
vaccinated with a pre-registration (COVID-19) vaccine
• Participation in a phase I/II/III medicine (pre-registration) trial
• Belonging to a risk group for COVID-19 that is studied in one of the
ZonMw-funded risk group vaccination studies (details of risk group studies
provided in ref.) that this study provides a comparison for:
o Primary (inherited) immune deficiency (VACOPID study)
o Severely decreased kidney function (defined as Chronic Kidney Disease stage 4
or 5 (eGFR<30)), treatment by dialysis or recipient of a kidney transplant
(RECOVAC study)
o Pulmonary disease for which the patient will receive or has received a lung
transplant (COVALENT study)
o Autoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to
B! (sub)study)
o Down syndrome (PRIDE study)
o (Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)
o Cancer patients and patients with active cancer treatment (including hormone
therapy), receipt of chemotherapy in the last 3 years and/or any history of
cancer immune therapy (VOICE study)
o Haematological patients, such as haematological malignancies (leukemia and
lymphomas), myelodysplastic and -proliferative syndromes, hemoglobinopathies
(sickle cell disease and thalassemia), receipt of stem cell transplantation or
cell therapy such as CAR T-cell therapy (COBRA-KAI study)
• Any other immune deficiency through disease
• Active or past immunosuppressive or immune modulating medication.
However, for steroid treatment the exclusion criteria are: receipt of any
high-dose (>= 20 mg of prednisone daily or equivalent) steroid treatment; daily
corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2
weeks of study entry; or repeated use of any high dose of corticosteroids (a
dose of > 30 mg of prednisone or equivalent per day for multiple days) in the
recent past.
• Women who are pregnant or breastfeeding
• Having a (functional) asplenia
• Receipt of blood products or immunoglobulin, within 3 months of study entry
• Receipt of an organ transplant not mentioned above
• For the subgroup: Known or suspected coagulation disorder, also by treatment,
that would contraindicate undergoing frequent blood sampling
Design
Recruitment
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 |
|---|---|
| Other | 2021-001357-31 |
| EudraCT | EUCTR2021-001357-31-NL |
| CCMO | NL76440.041.21 |