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

Immunosuppression Clinical Trial

— RituxiVac  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877496
• Other study ID #: 4749
• Status: Recruiting
• Start date: April 26, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2021
• Source: University Hospital Inselspital, Berne
• Contact: Daniel Sidler, MD PhD
• Phone: 0041316323144
• Email: daniel.sidler[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: October 31, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Immunosuppression
• Rituximab

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern Inselspital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral immune response to SARS-CoV2 spike protein	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)	At least 4 weeks after completion of COVID19 vaccination
Secondary	Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence	Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables.	At least 4 weeks after completion of COVID19 vaccination
Secondary	Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab		At least 4 weeks after completion of COVID19 vaccination
Secondary	Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.		At least 4 weeks after completion of COVID19 vaccination
Secondary	T cell anti-SARS-CoV2 response after COVID19 vaccination		At least 4 weeks after completion of COVID19 vaccination
Secondary	Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels	Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders.	At least 4 weeks after completion of COVID19 vaccination