Vaccination against SARS-CoV-2 in immunocompromised patients MedDRA version: 23.0 Level: LLT Classification code 10084462 Term: SARS-CoV-2 vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Cominranty concentrate for dispersion for injection
Product Name: Corminaty
Product Code: BNT162B2
Pharmaceutical Form: Injection
INN or Proposed INN: Tozinameran
Other descriptive name: S
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects will be eligible for participation in this study if they: • Are =18 years on the day of screening • Have a disease that is associated with a well characterized immunodeficiency (study population) • Treated with an immunosuppressive therapy (study population) • Have an immune-mediated disease without an immunosuppressive therapy, e.g. IBD patients solely with 5-ASA treatment (study population) • Are clinically healthy and not vaccinated with a SARS-CoV-2 vaccine (control group, age and sex-matched) • Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry 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 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: Are not willing to get SARS-CoV-2 Vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to estimate the humoral and cellular immune responses after mRNA vaccine against SARS-Cov-2 in adult patients with immunodeficiencies or treated with immunosuppressive/modulating therapy. Primary objective: To assess the humoral immunogenicity to a SARS-CoV-2 vaccine in immunosuppressed patients compared to healthy volunteers, the quantitative antibody levels will be measured by enzyme-linked immunosorbent assay test (ELISA) and in addition using neutralization test (NT) The null hypothesis has to be rejected that there is no difference in the seroconversion rate between the immunosuppressed patients and the healthy volunteers after SARS-CoV-2 vaccination ;Secondary Objective: Besides various biomedical analyzes, cellular immunogenicity of the SARS-Cov-2 vaccination in immunosuppressed patients, T cell proliferation will be assessed and T-cell cytokine expression will be measured using flow-cytometry after in vitro stimulation with peripheral blood mononuclear cells with SARS-Cov-2 antigen. Difference in humoral immunogenicity depending upon previous exposure to SARS-CoV-2 will be analyzed.;Primary end point(s): To assess the humoral immunogenicity of the SARS-Cov-2 vaccination, the outcome of ELISA test and neutralization test will be analyzed one month after the second vaccination. Therefore, the number of subjects with positive seroconversion rate against SARS-CoV-2 will be evaluated.;Timepoint(s) of evaluation of this end point: 28 days after second dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Antibody concentrations of SARS-CoV-2 ELISA before the first dose and six months after the second vaccination. • Increase of antibody responses after first and second vaccination • Evaluation of cellular immunity prior to and one week after the second vaccination. • Impact of the SARS-Cov-2 vaccine on disease activity of autoimmune/autoinflammatory disease • Difference in immune response in patients with chronic inflammatory diseases treated with various immunosuppressive therapies. • To develop algorithms utilizing clinical and laboratory data in order to predict the response to vaccination. • To assess the difference in humoral immunogenicity depending upon previous exposure to SARS-CoV-2. ;Timepoint(s) of evaluation of this end point: After first vaccination Six months after second vaccination | — |
Countries
Austria
Contacts
Public ContactSelma Tobudic
Medical University of Vienna
Outcome results
None listed