Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach
NCT ID: NCT04873128
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2021-06-10
2024-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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).
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.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
\- Missing informed consent of the subject
18 Years
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Olaf Rieß
Role: STUDY_DIRECTOR
University Hospital Tübingen
Locations
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University Hospital Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COVID 19-VAC
Identifier Type: -
Identifier Source: org_study_id