Clinical trial NCT04873128: Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach
Official title: Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genetic Predisposition
Keywords: Multi-OMICS
COVID-19
Side effect
Immun response
Vaccination
Memory response
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toll Like Receptor 7 (TLR7)
timeFrame: Day 1-3 before 1. vaccination
measure: Toll Like Receptor 7 (TLR7)
timeFrame: Day 7-10 after 1. vaccination
measure: Toll Like Receptor 7 (TLR7)
timeFrame: Day 1-3 before 2. vaccination
measure: Toll Like Receptor 7 (TLR7)
timeFrame: Day 7-10 after 2. vaccination
measure: Toll Like Receptor 7 (TLR7)
timeFrame: Month 6-12 after 2. vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Olaf Rieß
role: STUDY_DIRECTOR
References: