For assessing the immune cell function after COVID-19 vaccine, peripheral blood mononuclear cells (PBMC) will be separated after blood sampling and measurements as follows will be done: • FACS analysis • DNA and RNA analysis of immune related molecules. • Assays of T-cell function, B-cell function and macrophage/monocyte function
Conditions
Interventions
Trade Name: Spermidine (spermidineLIFE®, food supplement)
Product Name: SpermidineLIFE (dietary supplement)
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Spermidine
Other descri
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capacity to provide written informed consent 2. Age =65 and =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Incapacity to provide written informed consent 2. Active signs or symptoms of acute infection at the time of screening 3. Ongoing or previous SARS-CoV-2 vaccination 4. Positive SARS-CoV-2 PCR in the past or during the study period. 5. Glucocorticoid, immunosuppressive or other immune modifying therapy, current or within 3 months prior to first study visit 6. Medical history of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection 7. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation, current or within 3 months prior to first study intervention 8. Medical conditions that can suppress the immune system 9. Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct. 10. History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal 11. Previous allergy to vaccinations or their constituent parts 12. History of malignancies other than skin 13. Hypersensitivity to Spermidine or to any of its excipients 14. Gluten intolerance 15. Contraindication to vaccination 16. Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial 17. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this feasibility study is to determine the effects of daily Spermidine supplements on the immune response to the Covid-19 vaccine in older people. We will examine if Spermidine improves the age-related impaired immune response to the Covid-19 vaccine and determine the molecular and immunological signature driving immunity.;Secondary Objective: Our secondary objective is to determine the acceptability of daily Spermidine supplements to participants. We will also use data collected to perform a power calculation for future larger studies.;Primary end point(s): FACS analysis in peripheral blood mononuclear cells (PBMC) for deep immune phenotyping (focusing on T- and B-cell subtypes);Timepoint(s) of evaluation of this end point: At baseline, 2 weeks and 4 weeks after first COVID-19 vaccination, further 2 weeks and 26 weeks after 2nd vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cell sorting, using antibodies and fluorescent multimeric peptide-HLA molecules. • DNA and RNA analysis of immune related molecules. • Assays of T-cell function, including ELISPOT, ELISA, FACS surface staining, intracellular staining, cytokine secretion assays, cytotoxic function. • Assays of B-cell function, including ELISPOT, ELISA, FACS surface staining, intracellular staining, cytokine secretion assays. • Assays of macrophage/monocyte function, including ELISA, intracellular staining, cytokine secretion assays, phagocytosis, FACS. • In summary PBMCs will be isolated from peripheral blood, analysed by FACS, sorted for specific immune cell tests or used in functional assays. All cells will be disposed in virkon solution by the end of the day. • Immune cells sorted from PBMC may be used in DNA/RNA and proteomic analysis experiments, these cells will be rendered acellular on the day of separation during the process of the experiment. • Immune cells sorted from PBMC may be used in protein analysis experiments including western blot and proteomics, these cells will be rendered acellular on the day of separation during the process of the experiment. • Immune cells sorted from PBMC may be used in metabolite analysis experiments including detection of polyamines by GC-MS, these cells will be rendered acellular on the day of separation during the process of the experiment. ;Timepoint(s) of evaluation of this end point: At baseline, 2 weeks and 4 weeks after first COVID-19 vaccination, further 2 weeks and 26 weeks after 2nd vaccination (same as in primary end point) | — |
Countries
Austria
Contacts
Public ContactOliver Malle
Medical University of Graz
Outcome results
None listed