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Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab. (RituxiVac)

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ClinicalTrials.gov Identifier: NCT04877496
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date May 6, 2021
First Posted Date May 7, 2021
Last Update Posted Date June 2, 2021
Actual Study Start Date April 26, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2021)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2021)
  • 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 ]
    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 [ 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 ]
    Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.
Official Title Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Retention:   Samples Without DNA
Description:
PBMC
Sampling Method Non-Probability Sample
Study Population Participating Centers / Participating Departments: all at Bern University Hospital Insel)
Condition
  • COVID19 Vaccination
  • Rituximab
  • Immunosuppression
Intervention
  • Drug: History of exposure to anti-CD20 treatment since 01/01/2010
    Intravenous treatment history of anti-CD20 treatment since 01/01/2010
  • Biological: Completion of COVID19 vaccine at least 4 weeks ago
    Completion of COVID19 vaccination course at least 4 weeks ago.
Study Groups/Cohorts
  • Immunocompetent controls
    Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
    Intervention: 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
    Interventions:
    • Drug: History of exposure to anti-CD20 treatment since 01/01/2010
    • Biological: Completion of COVID19 vaccine at least 4 weeks ago
Publications * Moor MB, Suter-Riniker F, Horn MP, Aeberli D, Amsler J, Möller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2021)
425
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Exclusion Criteria:

Exclusion criteria for patients (any of the following)

  1. Patients 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. 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)

Exclusion criteria for volunteers (any of the following)

  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)
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Self-represented gender.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Daniel Sidler, MD PhD 0041316323144 daniel.sidler@insel.ch
Contact: Matthias B. Moor, MD PhD 0041316323144 matthias.moor@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04877496
Other Study ID Numbers 4749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Sidler, MD PhD University Hospital Bern, Department of Nephrology and Hypertension
PRS Account University Hospital Inselspital, Berne
Verification Date May 2021