Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.
NCT ID: NCT04877496
Last Updated: 2021-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
425 participants
OBSERVATIONAL
2021-04-26
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Immunocompetent controls
Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
Completion of COVID19 vaccine at least 4 weeks ago
Completion of COVID19 vaccination course at least 4 weeks ago.
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
History of exposure to anti-CD20 treatment since 01/01/2010
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
Completion of COVID19 vaccine at least 4 weeks ago
Completion of COVID19 vaccination course at least 4 weeks ago.
Interventions
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History of exposure to anti-CD20 treatment since 01/01/2010
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
Completion of COVID19 vaccine at least 4 weeks ago
Completion of COVID19 vaccination course at least 4 weeks ago.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. Pregnant or lactating women at time of study enrollment and/or
3. Patients who do not provide written informed consent and/or
4. Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
5. Patients who are in a dependency relationship with the study personnel (hierarchical, social)
1. Volunteers aged 18 years and younger at time of study enrollment and/or
2. Pregnant or lactating women at time of study enrollment and/or
3. Volunteers who do not provide informed consent and/or
4. Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
5. Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
6. Volunteers who did not complete their COVID19 vaccination
7. Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Daniel Sidler, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Department of Nephrology and Hypertension
Locations
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University Hospital Bern Inselspital
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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4749
Identifier Type: -
Identifier Source: org_study_id
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