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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunocompetent controls | Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment |
| |
| Patients with a treatment history of rituximab | Participants aged at least 18 years, no history of COVID19, history of at least 1 dose of anti-CD20 treatment received since 01/01/2010 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| History of exposure to anti-CD20 treatment since 01/01/2010 | Drug | Intravenous treatment history of anti-CD20 treatment since 01/01/2010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response to SARS-CoV2 spike protein | 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) | At least 4 weeks after completion of COVID19 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence | Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables. | At least 4 weeks after completion of COVID19 vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for patients (any of the following)
Exclusion criteria for volunteers (any of the following)
Self-represented gender.
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Participating Centers / Participating Departments: all at Bern University Hospital Insel)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sidler, MD PhD | Contact | 0041316323144 | daniel.sidler@insel.ch | |
| Matthias B. Moor, MD PhD | Contact | 0041316323144 | matthias.moor@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Sidler, MD PhD | University Hospital Bern, Department of Nephrology and Hypertension | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern Inselspital | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35361691 | Derived | Sidler D, Born A, Schietzel S, Horn MP, Aeberli D, Amsler J, Moller B, Njue LM, Medri C, Angelillo-Scherrer A, Borradori L, Seyed Jafari SM, Radonjic-Hoesli S, Chan A, Hoepner R, Bacher U, Mani LY, Iype JM, Suter-Riniker F, Staehelin C, Nagler M, Hirzel C, Maurer B, Moor MB. Trajectories of humoral and cellular immunity and responses to a third dose of mRNA vaccines against SARS-CoV-2 in patients with a history of anti-CD20 therapy. RMD Open. 2022 Mar;8(1):e002166. doi: 10.1136/rmdopen-2021-002166. | |
| 34514436 |
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PBMC
| Completion of COVID19 vaccine at least 4 weeks ago | Biological | Completion of COVID19 vaccination course at least 4 weeks ago. |
|
| 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 | Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders. | At least 4 weeks after completion of COVID19 vaccination |
| Derived |
| Moor MB, Suter-Riniker F, Horn MP, Aeberli D, Amsler J, Moller B, Njue LM, Medri C, Angelillo-Scherrer A, Borradori L, Radonjic-Hoesli S, Seyed Jafari SM, Chan A, Hoepner R, Bacher VU, Mani LY, Iype JM, Hirzel C, Maurer B, Sidler D. Humoral and cellular responses to mRNA vaccines against SARS-CoV-2 in patients with a history of CD20 B-cell-depleting therapy (RituxiVac): an investigator-initiated, single-centre, open-label study. Lancet Rheumatol. 2021 Nov;3(11):e789-e797. doi: 10.1016/S2665-9913(21)00251-4. Epub 2021 Sep 7. |
| ID | Term |
|---|---|
| D000073979 | F-Box-WD Repeat-Containing Protein 7 |
| ID | Term |
|---|---|
| D044843 | SKP Cullin F-Box Protein Ligases |
| D044767 | Ubiquitin-Protein Ligases |
| D043743 | Ubiquitin-Protein Ligase Complexes |
| D008025 | Ligases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D044783 | F-Box Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018797 | Cell Cycle Proteins |
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