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Clinical Trials/EUCTR2021-001391-42-AT
EUCTR2021-001391-42-AT
Active, not recruiting
Phase 1

Characterisation of the effects of Spermidine on the immune response to Covid-19 vaccine in older people - a feasibility study - Spermidine and Covid-19 vaccination in older people

Medical University of Graz0 sites40 target enrollmentApril 13, 2021
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ConditionsFor 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 functionTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsSpermidine (spermidineLIFE®, food supplement)

Overview

Phase
Phase 1
Intervention
Not specified
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
Sponsor
Medical University of Graz
Enrollment
40
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical University of Graz

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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