E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination against SARS-CoV-2 in immunocompromised patients |
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E.1.1.1 | Medical condition in easily understood language |
Vaccination against SARS-CoV-2 in patients with an inefficient immune system |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084462 |
E.1.2 | Term | SARS-CoV-2 vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal exclusion criteria |
Are not willing to get SARS-CoV-2 Vaccination |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 days after second dose |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After first vaccination Six months after second vaccination |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Vaccination response of immunocompromised Patients will be compared to non immunocompromised control |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |