Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach

Genetic Predisposition Clinical Trial

— COVID 19-VAC  

Official title:

Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873128
• Other study ID #: COVID 19-VAC
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: University Hospital Tuebingen
• Contact: Olaf Rieß, Prof. Dr.
• Phone: +49 7071 29
• Email: olaf.riess[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toll Like Receptor 7 (TLR7)	TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)	Day 1-3 before 1. vaccination
Primary	Toll Like Receptor 7 (TLR7)	TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)	Day 7-10 after 1. vaccination
Primary	Toll Like Receptor 7 (TLR7)	TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)	Day 1-3 before 2. vaccination
Primary	Toll Like Receptor 7 (TLR7)	TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)	Day 7-10 after 2. vaccination
Primary	Toll Like Receptor 7 (TLR7)	TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)	Month 6-12 after 2. vaccination