NCT04877496

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 6, 2021

Last Update Submit

May 27, 2021

Conditions

COVID19 VaccinationRituximabImmunosuppression

Keywords

B-cellsT-cellsCOVID19 vaccineSARS-CoV2Rituximab

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

Immunocompetent controls

Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment

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

Drug: History of exposure to anti-CD20 treatment since 01/01/2010Biological: Completion of COVID19 vaccine at least 4 weeks ago

Interventions

History of exposure to anti-CD20 treatment since 01/01/2010DRUG

Intravenous treatment history of anti-CD20 treatment since 01/01/2010

Patients with a treatment history of rituximab
Completion of COVID19 vaccine at least 4 weeks agoBIOLOGICAL

Completion of COVID19 vaccination course at least 4 weeks ago.

Immunocompetent controlsPatients with a treatment history of rituximab

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-represented gender.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating Centers / Participating Departments: all at Bern University Hospital Insel)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35361691DERIVED

  • 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.

    PMID: 34514436DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMC

MeSH Terms

Interventions

F-Box-WD Repeat-Containing Protein 7

Intervention Hierarchy (Ancestors)

SKP Cullin F-Box Protein LigasesUbiquitin-Protein LigasesUbiquitin-Protein Ligase ComplexesLigasesEnzymesEnzymes and CoenzymesF-Box ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsCell Cycle Proteins

Study Officials

  • Daniel Sidler, MD PhD

    University Hospital Bern, Department of Nephrology and Hypertension

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Sidler, MD PhD

CONTACT

0041316323144daniel.sidler@insel.ch

Matthias B. Moor, MD PhD

CONTACT

0041316323144matthias.moor@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 7, 2021

Study Start

April 26, 2021

Primary Completion

August 30, 2021

Study Completion

October 31, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)