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

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Germany
University Hospital Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Olaf Rieß, Prof. Dr.
olaf.riess@med.uni-tuebingen.de
+49 7071 29
Backup
Yogesh Singh, Dr.
yogesh.singh@med.uni-tuebingen.de
+49 7071 29
Time Frame
Start Date: 2021-06-10
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 110
Treatments
Experimental: Healthy adults
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).
Experimental: COVID-19 vaccinated subjects with side effects
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).
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov