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

University Hospital Tuebingen

Status: Enrolling

Conditions: Genetic Predisposition

Treatments: Genetic: Multi-OMICS

Study type: Interventional

Funder types: Other

Identifiers

NCT04873128

COVID 19-VAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Healthy adults

Experimental group

Description:

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).

Treatment:

Genetic: Multi-OMICS

COVID-19 vaccinated subjects with side effects

Experimental group

Description:

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).

Treatment:

Genetic: Multi-OMICS