COVID19 VaccinationRituxiVacNCT04877496
Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.
An observational study of COVID19 Vaccination and Rituximab, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19 Vaccination, Rituximab, Immunosuppression
- What is being tested?
- History of exposure to anti-CD20 treatment since 01/01/2010 and Completion of COVID19 vaccine at least 4 weeks ago
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 425 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Apr 2021to 31 Oct 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participating Centers / Participating Departments: all at Bern University Hospital Insel)
Who may be able to join
- Patients who were treated with anti-CD20 treatment since 01.01.2010
- 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)
- Volunteers without a history of anti-CD20 treatment exposure
- All: written informed consent.
Who cannot join
- Patients aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Patients who do not provide written informed consent and/or
- Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Patients who are in a dependency relationship with the study personnel (hierarchical, social)
- Volunteers aged 18 years and younger at time of study enrollment and/or
Show all 12Show fewer
- Pregnant or lactating women at time of study enrollment and/or
- Volunteers who do not provide informed consent and/or
- Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
- Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Volunteers who did not complete their COVID19 vaccination
- Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Bern Inselspital
Bern, Canton of Bern, 3010
Daniel Sidler, MD PhD, 00316323144, daniel.sidler@insel.ch
Matthias B. Moor, MD PhD, 0316323144, matthias.moor@insel.ch
About this study
Official title: Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
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.
- Conditions
- COVID19 Vaccination, Rituximab, Immunosuppression
- Being tested
- History of exposure to anti-CD20 treatment since 01/01/2010, Completion of COVID19 vaccine at least 4 weeks ago
- Keywords
- B-cells, T-cells, COVID19 vaccine, SARS-CoV2, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History of exposure to anti-CD20 treatment since 01/01/2010Drug
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
Completion of COVID19 vaccine at least 4 weeks agoBiological
Completion of COVID19 vaccination course at least 4 weeks ago.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompetent controls | Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment Receives: Biological: Completion of COVID19 vaccine 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 Receives: Drug: History of exposure to anti-CD20 treatment since 01/01/2010; Biological: Completion of COVID19 vaccine at least 4 weeks ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At least 4 weeks after completion of COVID19 vaccination
Secondary outcomes (5)
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.
Measured: At least 4 weeks after completion of COVID19 vaccination
Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab
Measured: At least 4 weeks after completion of COVID19 vaccination
Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.
Measured: At least 4 weeks after completion of COVID19 vaccination
T cell anti-SARS-CoV2 response after COVID19 vaccination
Measured: 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.
Measured: At least 4 weeks after completion of COVID19 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start26 Apr 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19 VaccinationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sidler, MD PhD, Principal investigator, University Hospital Bern, Department of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877496
- Sponsor's protocol ID
- 4749
- Acronym
- RituxiVac
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35361691Moor 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.
PubMed 34514436
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
- ClinicalTrials.gov ID
- NCT04877496
- Acronym / sponsor ID
- RituxiVac / 4749
- Conditions
- COVID19 Vaccination, Rituximab, Immunosuppression
- Keywords
- B-cells, T-cells, COVID19 vaccine, SARS-CoV2, Rituximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocompetent controls | – | Biological: Completion of COVID19 vaccine at least 4 weeks agoParticipants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment |
| Patients with a treatment history of rituximab | – | Drug: History of exposure to anti-CD20 treatment since 01/01/2010, Biological: Completion of COVID19 vaccine at least 4 weeks agoParticipants aged at least 18 years, no history of COVID19, history of at least 1 dose of anti-CD20 treatment received since 01/01/2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participating Centers / Participating Departments: all at Bern University Hospital Insel)
Key inclusion criteria (4 listed)
- Patients who were treated with anti-CD20 treatment since 01.01.2010
- 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)
- Volunteers without a history of anti-CD20 treatment exposure
- All: written informed consent.
Key exclusion criteria (12 listed)
- Patients aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Patients who do not provide written informed consent and/or
- Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Patients who are in a dependency relationship with the study personnel (hierarchical, social)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| History of exposure to anti-CD20 treatment since 01/01/2010Intravenous treatment history of anti-CD20 treatment since 01/01/2010 | Drug | Patients with a treatment history of rituximab |
| Completion of COVID19 vaccine at least 4 weeks agoCompletion of COVID19 vaccination course at least 4 weeks ago. | Biological | Immunocompetent controls, Patients with a treatment history of rituximab |
Primary outcome
Humoral immune response to SARS-CoV2 spike protein
Time frame: 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)
5 secondary outcomes
Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence
Time frame: At least 4 weeks after completion of COVID19 vaccination
Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab
Time frame: At least 4 weeks after completion of COVID19 vaccination
Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.
Time frame: At least 4 weeks after completion of COVID19 vaccination
T cell anti-SARS-CoV2 response after COVID19 vaccination
Time frame: 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
Time frame: At least 4 weeks after completion of COVID19 vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 35361691Sidler 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.
- Derived from this study: PubMed 34514436Moor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Sidler, MD PhD principal investigator
University Hospital Bern, Department of Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19 Vaccination and Rituximab, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Sidler, MD PhD (0041316323144, daniel.sidler@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response to SARS-CoV2 spike protein (time frame: At least 4 weeks after completion of COVID19 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877496, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.