Table A1.
Overview of study population, inclusion and exclusion criteria, and period of enrolment per cohort.
| Adolescent and Adult Cohort (18–60 Years) |
50+ Cohort (50–92 Years) |
|
|---|---|---|
| Invited population | Random sample of national population register (n = 80,000) | Participated in round 6 of Doetinchem Cohort Study [36,37] (n = 3147) |
| Participants in other studies by the Dutch National Institute of Public Health and the Environment (n = ~9500) | ||
| Spontaneous enrollment via website | ||
| Inclusion criteria | Planning to receive/received COVID-19 vaccination * | Planning to receive/received COVID-19 vaccination * |
| Able and willing to participate and sign IC | Able and willing to participate and sign IC | |
| Exclusion criteria | Participation in a phase I/II/III preregistration vaccination trial or a phase I/II/III medicine (pre-registration) trial | None |
| Belonging to a high-risk group for COVID-19 already studied in a risk group vaccination study that this study provides as a comparison for ** | ||
| Any other immune deficiency through disease | ||
| Active or past immunosuppressive or immune modulating medication *** | ||
| Women who are pregnant or breastfeeding | ||
| Having (functional) asplenia | ||
| Receipt of blood products or immunoglobulin, within 3 months of study entry | ||
| Receipt of organ transplant not mentioned in a high-risk group list | ||
| Period of enrolment | April to October 2021 | March to August 2021 |
* Latest enrolment: within one month following second vaccination. ** Primary (inherited) immune deficiency, severely decreased kidney function (defined as chronic kidney disease stage 4 or 5; eGFR < 30), treatment by dialysis or recipient of a kidney transplant, pulmonary disease for which the patient will receive or has received a lung transplant, autoimmune disease (e.g., MS, rheumatoid arthritis, IBD, SLE, etc.), Down syndrome, (known) infection with Human Immunodeficiency Virus (HIV), 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, haematological patients, such as haematological malignancies (leukemia and lymphomas), myelodysplastic and -proliferative syndromes, hemoglobinopathies (sickle cell disease and thalassemia), or receipt of stem cell transplantation or cell therapy such as CAR T-cell therapy.*** For steroid treatment, the exclusion criteria were: 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.