Active immunisation to prevent COVID-19 in immunocompromised individuals. MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria: 1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement. or 2. Patients with primary immunodeficiencies or 3. Patients with B-cell depleting therapy due autoimmune disease or 4. Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies. or 5. Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment. or 6. Patients >3 months but 3 months but 12 months after allogeneic HSCT but under immunosuppressive therapy. or 9. Patients with chronic GvHD and persistent immunodeficiency. 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 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 195
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria cannot be enrolled into the trial: Healthy participants 1. Presence of diseases or therapies that are likely to interfere with the immune response to vaccination. 2. Presence of a disease requiring change in therapy during 4 weeks before enrollment. 3. Any contraindications to the vaccine planned to receive as listed in the product characteristics. 4. Lack of willingness to undergo serial blood draws and attend follow-up appointments. 5. Women who are pregnant or breastfeeding. 6. Previous vaccination with any coronavirus vaccine. 7. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent). Immunodeficient participants 1. Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells). 2. Patients with hematological malignancies in remission and >12 months after end of specific therapy. 3. Patients within three months from HSCT. 4. Any contraindications to the vaccine planned to receive as listed in the product characteristics. 5. Lack of willingness to undergo serial blood draws and attend follow-up appointments. 6. Women who are pregnant or breastfeeding. 7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank). 8. Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 21-28 after the second vaccination.;Main Objective: Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.;Primary end point(s): The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls. ;Secondary Objective: Compare T cell response of healthy & immunodeficient subject Differnce in seroconversion or T cell response between different vaccines Impact of immune system´s aging to humoral & cellular immune response Impact of the various forms of immunosuppression on the vaccine-induced response Impact of previous SARS-CoV-2 infection and Role of previous asymptomatic SARS-CoV-2 infection on the vaccine induced response Compare immune response of the various vaccines & participants Difference in the induction of secretory IgA and serum IgA in comparison to the serum IgG and IgM response Influence of previous infections caused by endemic CoV on the vaccine response Difference in the induction of neutralizing antibodies in subsets of immunocompromised & in COVID-19 recovered individuals compared to COVID-19 naïve controls Difference in the neutralizing capacity of antibodies after vaccination towards the emerging SARS-CoV-2 variants Humoral & cellular effect of a booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Seroconversion measured by SARS-CoV-2 antigen-binding Ig assay 6 and 12 months after second, 3-5 weeks and 6 months after third vaccination • Concentrations of recombinant S protein-binding IgG depending on prior exposure to SARS-CoV-2. • Concentrations of secretory and serum IgA in comparison to IgG and IgM after second and third vaccination in immunocompromised, in recovered individuals and in healthy controls. • Cytokine production of T cells after SARS-CoV-2 antigen exposure, measured by FACS and ELISpot • Identification of parameters predicting the response to COVID-19 vaccinations: prior CoV infection (cross-reactive antibodies), quantitative immunoglobulins, B cell subsets, T cell subsets; T cell aging (TCR diversity, telomere length, TREC levels) • Neutralizing capacity of antibodies in respect of different SARS-CoV-2 variants • Correlation of dietary inflammation index and subcutaneous fat thickness sum with seroconversion after second vaccination.;Timepoint(s) of evaluation of this end point: After second and third vaccination and 6 and months after vaccination, respectively. | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
Medical University of Graz
Outcome results
None listed