An interventional study of Multi-OMICS in Genetic Predisposition, sponsored by University Hospital Tuebingen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Diagnostic
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1
Group 2
Exclusion Criteria:
Group 1 and 2
Healthy adults who had no infection with SARS-CoV-2 virus before or had recovered from COVID-19 and plan to take the various COVID-19 experimental vaccine candidates or had already one dose of COVID-19 vaccine and are going to have the second vaccination with a different vaccine. Study related procedures: 1-3 days before application of the first vaccine dose (blood sample 1) 7-10 days after first dose of vaccine (blood sample 2), 1-3 days before second dose of vaccine (blood sample 3) 7-10 days after second vaccine dose (blood sample 4) 6-12 Months after second vaccine dose (blood sample 5, optional) Next Generation Sequencing (NGS) analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Genetic: Multi-OMICS
COVID-19 vaccinated subjects with diagnosed central thrombosis, anaphylactic shock or other major or minor complications such as dermatitis. Study related procedures: Blood sample will be taken without time frame 1-3 days after admission to the hospital (severe side effects) or consulting a doctor (mild side effects) (blood sample 1) during treatment (blood sample 2) After subject is recovered (blood sample 3) 6-12 Months after recovering (blood sample 4, optional) Next Generation Sequencing (NGS) analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Genetic: Multi-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.
Toll Like Receptor 7 (TLR7)
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Time frame: Day 1-3 before 1. vaccination
Toll Like Receptor 7 (TLR7)
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Time frame: Day 7-10 after 1. vaccination
Toll Like Receptor 7 (TLR7)
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Time frame: Day 1-3 before 2. vaccination
Toll Like Receptor 7 (TLR7)
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Time frame: Day 7-10 after 2. vaccination
Toll Like Receptor 7 (TLR7)
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Time frame: Month 6-12 after 2. vaccination
Plan to share: Yes — The COVID19-VAC study will provide data in a pseudonymised manner to national and international databases set up to increase the diagnostic yield through advanced analysis tools and matchmaking against other cohorts
Supporting information: Analytic code
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University Hospital Tuebingen