Immune responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects
- Conditions
- immuunsysteemcoronaprevention10047438
- Registration Number
- NL-OMON51214
- Lead Sponsor
- Ministerie van Volksgezondheid, Welzijn en Sport (VWS)
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1459
• 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
• 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter of the study is COVID-19 vaccine (e.g. Spike<br /><br>protein)-specific serum IgG (GMC) at day 28 after completion of COVID-19<br /><br>vaccination, by multiplex immune assay (MIA). </p><br>
- Secondary Outcome Measures
Name Time Method <p>a. Humoral, cellular and innate COVID-19 vaccine-induced immune responses<br /><br>b. Virus neutralizing capacity of antibodies induced by COVID-19 vaccination<br /><br>c. Fc functionality of antibodies (e.g. complement deposition) and antibody<br /><br>glycosylation status induced by COVID-19 vaccination<br /><br>d. COVID-19 vaccine-induced antibodies in nasal mucosal lining fluid<br /><br>e. Reactogenicity self-reported in questionnaires shortly after vaccination</p><br>