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

NCT04873128 | Unknown

• 1 other identifier: COVID 19-VAC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic Predisposition

Keywords

Multi-OMICS; COVID-19; Side effect; Immun response; Vaccination; Memory response

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Healthy adults

EXPERIMENTAL

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).

Genetic: Multi-OMICS

COVID-19 vaccinated subjects with side effects

EXPERIMENTAL

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).

Genetic: Multi-OMICS

Interventions

Multi-OMICS GENETIC

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; Healthy adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Group 1 and 2
• \- Missing informed consent of the subject

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to Disease; COVID-19

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Olaf Rieß

  University Hospital Tübingen

  STUDY DIRECTOR

Central Study Contacts

Olaf Rieß, Prof. Dr.

CONTACT

+49 7071 29; olaf.riess@med.uni-tuebingen.de

Yogesh Singh, Dr.

CONTACT

+49 7071 29; yogesh.singh@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: June 10, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available after analysis and unlimited.

Locations

DE (1)