Study of the immune response after corona vaccinatio
- Conditions
- Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjectsTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-001357-31-NL
- Lead Sponsor
- ational Institute of Health and the Environment
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2100
• 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 protocol ref. [9,10,11]) that this study provides a comparison for:
oPrimary (inherited) immune deficiency (VACOPID study)
oSeverely 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)
oPulmonary disease for which the patient will receive or has received a lung transplant (COVALENT study)
oAutoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to B! (sub)study)
oDown syndrome (PRIDE study)
o(Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)
oCancer 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)
oHaematological 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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method