Vaccination against SARS-CoV-2 in patients with rituximab therapy
Conditions
Interventions
Trade Name: Comirnaty concentrate for dispersion for injection
Product Name: Comirnaty
Product Code: BNT162B2
Pharmaceutical Form: Injection
INN or Proposed INN: Biontech/Pfizer
CAS Number: 2417899-77
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Male and female subjects will be eligible for participation in this study if they: 1. Are =18 years on the day of screening 2. Have a chronic condition and have been treated with a B-cell depleting therapy (rituximab) within the last 12 months 3. Received mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) vaccine 4. Did not develop humoral immunity 4 weeks after second mRNA vaccination to SARS-CoV-2 (analyzed during the study “Characterization of immune responsiveness after mRNA SARS-CoV-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK-Nr. 1073/2021, EudraCT Nr. 2021-000291-11) 5. A maximum of 6 months after second vaccination 6. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry 7. If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects will be excluded from participation in this study if they: 1. Have shown humoral response to the SARS-CoV-2 vaccination 2. Had grade 3 adverse effects from the mRNA vaccination reported 3. Pregnancy and breast feeding 4. Signs of SARS-CoV-2 infection (including previous positive PCR testing) 5. Any other contraindication to any of the study compounds 6. Urgent need for next rituximab application
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study endpoints: The secondary endpoints of this study are: Overall SARS-Cov-2 antibody seroconversion rate by week 4 after vaccination boost at baseline Difference in overall SARS-Cov-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between patient with and without B-cell repopulation. Antibody concentrations of SARS-CoV-2 ELISA 4 weeks after vaccination boost at baseline. Effect of immunosuppressive comedication on SARS-Cov-2 antibody seroconversion rate by week 4 after vaccination boost at baseline Evaluation of cellular immunity before and one week after the vaccination. Safety of vaccination boost. ;Timepoint(s) of evaluation of this end point: one week and four weeks after SARS-CoV-2 vaccination | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to investigate the humoral and cellular immune responses after a second boost vaccination with either an mRNA or an vector vaccine against SARS-CoV-2 in adult patients treated with rituximab who did not develop antibodies to the first two vaccinations with an mRNA vaccine. Primary Objective: To assess the immunogenicity to a third vaccination mRNA-SARS-CoV-2 vaccine (Biontech/Pfizer or Moderna) compared to a vector SARS-CoV-2 (AstraZeneca) vaccination as a second boost in patients with rituximab by measuring quantitative antibody levels by enzyme-linked immunosorbent assay test (ELISA) and neutralization test (NT) or pseudo viral neutralization assay. Null hypothesis: There is no statistical difference in the seroconversion rate between patients receiving a third mRNA vaccination and the patients receiving a second boost with AstraZeneca. ;Secondary Objective: Secondary Objectives To compare cellular immunogenicity of the third mRNA SARS-Cov-2 vaccination will be compared to patients receiving AstraZeneca vaccination as second boost in immunosuppressed patients. T cell proliferation will be assessed, and T-cell cytokine expression will be measured using flow-cytometry following in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with SARS-Cov-2 specific antigens. To assess safety of a second boost vaccination. To evaluate the influence of vaccination on underlying disease activity.;Primary end point(s): Primary study endpoint Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca). ;Timepoint(s) of evaluation of this end point: 4 weeks after SARS-CoV-2 vaccination | — |
Countries
Austria
Contacts
Public ContactSelma Tobudic
Medical University of Vienna
Outcome results
None listed