Clinical trial NCT04871932: COVID-2019 Vaccine Immune Response Base on Single Cell Multi-Omics
Official title: Evolution of Immune System in Healthy Adults After Vaccination of New Coronavirus (COVID-2019) Inactivated Vaccine Based on Single Cell Multi-Omics Technologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune System and Related Disorders
Keywords: Cohort study
Immune System
PBMC
China
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults with Han nationality

Brief summary: In recent years, single-cell high-throughput sequencing technology has developed rapidly and is widely used in research related to the immune system, breaking traditional cognition and gaining a new understanding of immune cell classification. In particular, the emerging single cell RNA sequencing (scRNA-seq) provides new ideas for the study of cell heterogeneity in multicellular organisms. Analyzing the changes in the expression profile of the cell transcriptome at the single-cell level can clearly show the changes in the trajectory of individual cells, reveal new cell types, and discover the potential functions of immune cells. Therefore, this study intends to recruit healthy adults and use multi-omics techniques such as single-cell sequencing to systematically classify the peripheral blood mononuclear cells of healthy adults to provide a basis for further disease-related research.

Detailed description: As an important part of the human body, the immune system is closely related to the occurrence of diseases. Based on the traditional classification methodology, it is mainly divided into two branches: innate immunity and adaptive immunity. Innate immune cells mainly include monocytes (Mono), natural killer (NK) cells and dendritic cells (DC). The adaptive immune cells mainly include B lymphocytes (B) and T lymphocytes (T). Peripheral blood mononuclear cells (PBMCs) mainly include T cells, B cells, NK cells, Mono cells and DC cells.

The proportion of these cell populations varies among individuals. Usually in PBMC, T lymphocytes account for 45-70%, B cells account for 5-15%, NK cells account for 5-20%, Mono cells account for 10-30%, and DC cells account for 1-2%. Among them, B cells can be divided into transitional, naive, memory subgroups and plasma cells. While, T cells are mainly composed of cluster of differentiation 4+ (CD4+) T cells and cluster of differentiation 8+ (CD8+) T cells with the ratio about 2:1. What's more, CD4+ T cells and CD8+ T cells can be further divided into naive cells, central memory cells in contact with antigen, effector memory cells and effector cells. Mono cells can be divided into classic monocytes and non-classical cluster of differentiation 16+ (CD16+) pro-inflammatory monocytes. DC cells include plasmacytic dendritic cells (pDC) and myeloid dendritic cells (mDC).

In recent years, scRNA-seq has developed rapidly and is widely used in research related to the immune system, breaking traditional cognition and gaining a new understanding of immune cell classification. In particular, the emerging scRNA-seq provides new ideas for the study of cell heterogeneity in multicellular organisms. Analyzing the changes in the expression profile of the cell transcriptome at the single-cell level can clearly show the changes in the trajectory of individual cells, reveal new cell types, and discover the potential functions of immune cells.

Adults have a relatively stable immune system, with little interference from the external environment. Therefore, this study intends to recruit healthy adults and use multi-omics techniques such as scRNA-seq to systematically classify the PBMCs of healthy adults to provide a basis for further disease-related research.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 50 years; 2. No history of major diseases, no history of bacterial or viral infection in the past 3 months; 3. No recent history of surgery or trauma; 4 No history of smoking or alcoholism; 5. No immune system disease.

Exclusion Criteria:

1. Infectious diseases; 2. Tumor diseases; 3. Hematological diseases; 4. History of hypertension and diabetes; 5 Autoimmune diseases; 6 History of liver and kidney insufficiency; 7. History of previous cardiovascular diseases; 8. Pregnancy Or breast-feeding; 9. Past and current use of immunosuppressive drugs

Primary outcomes:
measure: Changes in classification of human peripheral blood mononuclear cells
timeFrame: up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiology, Ren Ji Hospital
Study officials:
affiliation: Cardiology, Ren Ji Hospital Shanghai, China
name: Jun Pu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: