Genetic Predisposition
Conditions
Keywords
Multi-OMICS, COVID-19, Side effect, Immun response, Vaccination, Memory response
Brief summary
Reaction of the immune system and the body to a Coronavirus-19 (COVID-19) vaccination is so different and ultimately unpredictable has not yet been clarified. It is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. Using high-throughput dissecting (analytical) methods with the suffix OMICS (Multi-OMICS methods, collective characterization and quantification of pools of biological molecules) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels.
Detailed description
Various vaccines against COVID-19 (CORONA) have now been approved in Germany. How and why the reaction of the immune system and the body to a COVID-19 vaccination is so different and ultimately unpredictable has not yet been clarified. It is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. There are now initial indications that genetic prerequisites can play a role in the development of the immune response. Furthermore, we want to examine the long-term protection against Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) infection through vaccination and learn to understand it better. Using high-throughput dissecting (analytical) methods with the suffix OMICS (Multi-OMICS method) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels. The expected results can help to gain a better understanding of the underlying reactions to a COVID-19 vaccination and the functioning of the body (pathophysiology) in the future, which could enable the basis for the development of causal therapeutic approaches and improved vaccines.
Interventions
GENETICMulti-OMICS
Measurement of gene expression in immune cells (Human Peripheral Blood Mononuclear Cell (PBMCs) or total blood) using functional genomics, proteomics, metabolomics and lipidomics tools and compare the dynamics of immune response before and after vaccination against COVID-19.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Group 1 * Healthy donors (HD) who had recovered from COVID-19 disease and/or HD who did not have COVID-19 disease in the past * and who will receive the COVID-19 vaccine or a COVID19 vaccine candidate or other protective vaccines * HD who did receive one dose of a specific COVID19 vaccine but who will receive a different vac-cine for her/his second vaccination for completion of the immunization * Age \> 18 years Group 2 * Vaccinated subjects who are diagnosed with central thrombosis, anaphylactic shock or other major or minor complications such as atopic dermatitis (for example) after vaccination. * Age \> 18 years
Exclusion criteria
Group 1 and 2 \- Missing informed consent of the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toll Like Receptor 7 (TLR7) | Day 1-3 before 1. vaccination | TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP) |
Countries
Germany
Contacts
Primary ContactOlaf Rieß, Prof. Dr.
Backup ContactYogesh Singh, Dr.
Outcome results
None listed