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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04877496

Collaborator

(none)

425

Enrollment

Location

6.2

Anticipated Duration (Months)

68.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

425 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.

Actual Study Start Date :

Apr 26, 2021

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

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

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria for patients (any of the following)

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)

Exclusion criteria for volunteers (any of the following)

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)