An observational study in Covid19 and Immunosuppression, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Medical University of Graz · Observational
Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. The investigators will assess the humoral and cellular response to COVID-19 vaccination in these subjects in detail. Furthermore, factors associated with good response to vaccination will be identified. The results of this study will help to guide future recommendations on COVID-19 vaccination in this population.
The total duration of the study is 38 months, starting in March 2021 with a recruiting period until 31. December 2021 and termination of all scheduled visits until 31 May 2024. Individuals having consented and fulfilling the inclusion and exclusion criteria are included in the trial. A baseline visit will take place up to 60 days before the planned date of vaccination according to the Austrian vaccination plan. Scheduled vaccination with any COVID-19 vaccine approved in Austria will allow recruitment. If appropriate pre-vaccine samples from study participants exist in the biobank of the Medical University of Graz, patients may also be included in the study after vaccination starting with visit 3. In this case the biomaterial available at the biobank will be used for the analyses planned on visit 1. The investigators will not influence the date of vaccination or the type of the vaccine used. After first vaccination a telephone visit (visit 2) will assess adverse events and schedule visit 3 at the appropriate time after the second vaccination. At visit 3 the patient's vaccination certificate will be checked to verify correct vaccination and document the type of vaccine received. Further visits (5-6) will be performed for up to two years after the second vaccination. This follow-up period will allow an assessment of the duration of the immune response. The data recorded directly on the Case Report Form (CRF) are considered to be source data. COVID-19 vaccination, COVID-19 infection, Vaccination history, Pregnancy test, Adverse Events, BMI (Body Mass Index), and Laboratory Specimen Collection are recorded directly on the CRF and therefore are considered to be source data. Data will be merged in an electronic database (RDA Research, Documentation \& Analysis; Medical University of Graz, version 07.03.2019). Case Report Forms (CRFs) will be inspected in respect of their accuracy and completeness and compared to original data by the monitor.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 373 is above the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Immunodeficient participants and immunocompetent participants (i.e., healthy participants)
Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
or
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
Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. chronic lymphatic leukemia, MM) currently not receiving specific treatment.
or
Patients >3 months but \<12 months after autologous HSCT (hematopoietic stem cell transplantation).
or
Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
or
Exclusion Criteria:
Healthy participants
Immunodeficient participants
Patients with primary or secondary immunodeficiency planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan.
Diagnostic Test: Blood sample · Diagnostic Test: Saliva sample
Healthy people planning on vaccination against SARS CoV-2 according to the Austrian vaccination plan.
Diagnostic Test: Blood sample · Diagnostic Test: Saliva sample
Serology, immune status, T cell immunity, and T cell aging.
Antibody tests
The levels of anti-SARS-CoV-2 spike protein humoral immune response.
The levels of anti-SARS-CoV-2 (severe acute respiratory syndrome-Covid Virus) spike protein humoral immune response measured by SARS-CoV-2 antigen-binding Ig assay comparing immunocompromised patients to healthy controls.
Time frame: At day 21-28 after the second vaccination
Seroconversion
Change of Seroconversion measured by SARS-CoV-2 antigen-binding Ig assay 6, 12 and 24 months after vaccination.
Time frame: 6, 12 and 24 months after vaccination.
Concentrations of recombinant S protein-binding IgG (immunoglobulin G)
Change of Concentrations of recombinant S protein-binding IgG after second vaccination in comparison to response after first vaccination.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Concentrations of secretory and serum IgA in comparison to IgG and IgM (immunoglobulin M)
Change of Concentrations of secretory and serum IgA in comparison to IgG and IgM after second vaccination in immunocompromised, in recovered individuals and in healthy controls.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
IFNγ production of T cells
Change of IFNγ (Interferone gamma) production of T cells after SARS-CoV-2 antigen exposure, measured by FACS (fluorescence-activated cell sorter) and ELISpot.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Cross-reactive antibodies predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: prior CoV infection (cross-reactive antibodies). Evaluation of the influence of previous infections caused by endemic CoV (proven through cross-reactive antibodies) on the vaccine response in immunocompromised individuals and in COVID-19 recovered individuals compared to controls.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Quantitative immunoglobulins predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: quantitative immunoglobulins.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
B cell subsets predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: B cell subsets.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell subsets predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: T cell subsets.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
T cell aging predicting the response to COVID-19 vaccinations
Identification of parameters predicting the response to COVID-19 vaccinations: T cell aging (TCR diversity, telomere length, TREC levels).
Time frame: 60-0 days before first vaccination.
Occurence of neutralizing antibodies by means of SARS-CoV-2 neutralizing assays.
Neutralizing capacity of antibodies in respect of different SARSCoV-2 variants.
Time frame: At day 21-28 as well as 12 and 24 months after the second vaccination.
Correlation of diet and body fat with seroconversion
Correlation of diet and body fat with seroconversion after second vaccination.
Time frame: At day 21-28 and 12 months after the second vaccination.
Plan to share: No
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