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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877496
Recruitment Status : Unknown
Verified May 2021 by University Hospital Inselspital, Berne.
Recruitment status was:  Recruiting
First Posted : May 7, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.

Condition or disease Intervention/treatment
COVID19 Vaccination Rituximab Immunosuppression Drug: History of exposure to anti-CD20 treatment since 01/01/2010 Biological: Completion of COVID19 vaccine at least 4 weeks ago

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received. [ Time Frame: At least 4 weeks after completion of COVID19 vaccination ]
  4. T cell anti-SARS-CoV2 response after COVID19 vaccination [ Time Frame: At least 4 weeks after completion of COVID19 vaccination ]
  5. 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.


Biospecimen Retention:   Samples Without DNA
PBMC

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-represented gender.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participating Centers / Participating Departments: all at Bern University Hospital Insel)
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877496


Contacts
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Contact: Daniel Sidler, MD PhD 0041316323144 daniel.sidler@insel.ch
Contact: Matthias B. Moor, MD PhD 0041316323144 matthias.moor@insel.ch

Locations
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Switzerland
University Hospital Bern Inselspital Recruiting
Bern, BE, Switzerland, 3010
Contact: Daniel Sidler, MD PhD    00316323144    daniel.sidler@insel.ch   
Contact: Matthias B. Moor, MD PhD    0316323144    matthias.moor@insel.ch   
Principal Investigator: Daniel Sidler, MD PhD         
Sub-Investigator: Matthias B Moor, MD PhD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Daniel Sidler, MD PhD University Hospital Bern, Department of Nephrology and Hypertension
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04877496    
Other Study ID Numbers: 4749
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
B-cells
T-cells
COVID19 vaccine
SARS-CoV2
Rituximab
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases