Effects of Spermidine intake on the immune response to Covid-19 vaccine

Phase 1

• Conditions: 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; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-001391-42-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Capacity to provide written informed consent
2.Age =65 and <90 years at consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified