immunocompromised patients patients with decreased defense against infections
Conditions
Interventions
None listed
Sponsors
Interne Geneeskunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Study participant belongs to either of the 6 defined groups and is planned for vaccination with the BNT162b2 or the mRNA1273 vaccine according to the National Institute for Public Health guideline, i.e.: • Inflammatory bowel disease and on treatment for at least 6 weeks with anti-TNF agents (infliximab, adalimumab and biosimilars) • post kidney transplantation and on immunosuppressants • Treated with B-cell depleting, antiCD20 (Obinituzumab or Rituximab) monotherapy for a hematological malignancy in the past 6 months • Chronic lymphocytic leukemia (CLL), irrespective of stage, not treated for CLL in the past 6 months prior to the first vaccination and no treatment expected within 4 weeks of the second vaccination • Advanced solid malignancy and on treatment for at least 6 weeks with one or more of the following agents: doxorubicin, cyclophosphamide, docetaxel, cisplatinum, etoposide, irinotecan • healthy volunteers • Study participant is older than 17 years and willing to undergo vaccination • Study participant is able to give written informed consent • Study participant is able to visit the ADRZ for the scheduled laboratory visits
Exclusion criteria
Exclusion criteria: History of a documented SARS COV-2 infection Considered as high risk for a hypersensitivity reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine efficacy ( SARS CoV incidence within a follow up of at least 2 years) Quality and quantity of the antbody response to the vaccines in 5 patient groups compared to healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects after first and second vaccination | — |
Countries
Netherlands
Outcome results
None listed