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

Insel Gruppe AG, University Hospital Bern

Status: Unknown

Conditions: COVID19 Vaccination; Immunosuppression; Rituximab

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

Study type: Observational

Funder types: Other

Identifiers

NCT04877496

4749

Details and patient eligibility

About

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.

Enrollment: 425 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

425 participants in 2 patient groups

Immunocompetent controls

Description:

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

Treatment:

Biological: Completion of COVID19 vaccine at least 4 weeks ago

Patients with a treatment history of rituximab

Description:

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

Treatment:

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

Biological: Completion of COVID19 vaccine at least 4 weeks ago