COVID19 Vaccination, Immunosuppression, Rituximab
Conditions
Keywords
B-cells, T-cells, COVID19 vaccine, SARS-CoV2, Rituximab
Brief summary
Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vaccination. Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.
Interventions
DRUGHistory of exposure to anti-CD20 treatment since 01/01/2010
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
BIOLOGICALCompletion of COVID19 vaccine at least 4 weeks ago
Completion of COVID19 vaccination course at least 4 weeks ago.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients who were treated with anti-CD20 treatment since 01.01.2010 2. Patients who received a COVID19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment) 3. Volunteers without a history of anti-CD20 treatment exposure 4. All: written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response to SARS-CoV2 spike protein | At least 4 weeks after completion of COVID19 vaccination | Percentage of all patients developing IgG antibodies against SARS-CoV2 spike protein that is comparable to the immunological response in immunocompetent controls (-2 standard deviations of mean) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence | At least 4 weeks after completion of COVID19 vaccination | Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables. |
| Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab | At least 4 weeks after completion of COVID19 vaccination | — |
| Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received. | At least 4 weeks after completion of COVID19 vaccination | — |
| T cell anti-SARS-CoV2 response after COVID19 vaccination | At least 4 weeks after completion of COVID19 vaccination | — |
| Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels | At least 4 weeks after completion of COVID19 vaccination | Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders. |
Countries
Switzerland
Contacts
Primary ContactDaniel Sidler, MD PhD
Backup ContactMatthias B. Moor, MD PhD
Outcome results
None listed