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

• Conditions: Immunosuppression; COVID19 Vaccination; Rituximab
• Interventions: Drug: History of exposure to anti-CD20 treatment since 01/01/2010; Biological: Completion of COVID19 vaccine at least 4 weeks ago

• Registration Number: NCT04877496
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 available

Study Timeline

• Study Start: 2021-04-26
• Status Verified: 2021-05
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-02
• Primary Completion: 2021-08-30
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 425

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a treatment history of rituximab	Completion of COVID19 vaccine at least 4 weeks ago	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
Immunocompetent controls	Completion of COVID19 vaccine at least 4 weeks ago	Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
Patients with a treatment history of rituximab	History of exposure to anti-CD20 treatment since 01/01/2010	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

Primary Outcome Measures

Name	Time	Method
Humoral immune response to SARS-CoV2 spike protein	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

Name	Time	Method
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	Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders.
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	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	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

Trial Locations

Locations (1)

University Hospital Bern Inselspital; 🇨🇭 Bern, BE, Switzerland