Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Toll Like Receptor 7 (TLR7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •Group 1 and 2
- •Missing informed consent of the subject
研究组 & 干预措施
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).
干预措施: Multi-OMICS (Genetic)
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).
干预措施: Multi-OMICS (Genetic)
结局指标
主要结局
Toll Like Receptor 7 (TLR7)
时间窗: Month 6-12 after 2. vaccination
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Toll Like Receptor 7 (TLR7)
时间窗: Day 1-3 before 1. vaccination
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Toll Like Receptor 7 (TLR7)
时间窗: Day 7-10 after 1. vaccination
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Toll Like Receptor 7 (TLR7)
时间窗: Day 1-3 before 2. vaccination
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
Toll Like Receptor 7 (TLR7)
时间窗: Day 7-10 after 2. vaccination
TLR7 (used method: Whole Genome Sequencing (WGS) using ordinal logistic regression) measured in Single Nucleotide Polymorphism (SNP)
次要结局
未报告次要终点