COVID-2019 Vaccine Immune Response Base on Single Cell Multi-Omics

NCT ID: NCT04871932

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-12-03

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.

Conditions

Immune System and Related Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Recently unvaccinated group (Female)

This study intends to collect peripheral blood from healthy adults aged 18 to 50 years. Gender and vaccination may be independent potential factors that affect the changes in peripheral blood immune cells. This study collects basic clinical information from volunteers, and classifies the population based on gender and whether they have been vaccinated recently (including influenza vaccine, human papillomavirus \[HPV\] vaccine, and severe acute respiratory syndrome \[SARS\]-CoV-2 vaccines and others), aiming at systematically classify the peripheral blood mononuclear cells of healthy adults under different conditions and search for molecular markers related to different cell types. This group is Recently unvaccinated group (Female)．

No interventions assigned to this group

Recently unvaccinated group (Male)

This study intends to collect peripheral blood from healthy adults aged 18 to 50 years. Gender and vaccination may be independent potential factors that affect the changes in peripheral blood immune cells. This study collects basic clinical information from volunteers, and classifies the population based on gender and whether they have been vaccinated recently (including influenza vaccine, HPV vaccine, and SARS-CoV-2 vaccines and others), aiming at systematically classify the peripheral blood mononuclear cells of healthy adults under different conditions and search for molecular markers related to different cell types. This group is Recently unvaccinated group (Male)．

No interventions assigned to this group

Recently vaccinated group (Female)

This study intends to collect peripheral blood from healthy adults aged 18 to 50 years. Gender and vaccination may be independent potential factors that affect the changes in peripheral blood immune cells. This study collects basic clinical information from volunteers, and classifies the population based on gender and whether they have been vaccinated recently (including influenza vaccine, HPV vaccine, and SARS-CoV-2 vaccines and others), aiming at systematically classify the peripheral blood mononuclear cells of healthy adults under different conditions and search for molecular markers related to different cell types. This group is Recently vaccinated group (Female)．

Recently Vaccination

Intervention Type: BIOLOGICAL

Recently vaccinated group (Male)

This study intends to collect peripheral blood from healthy adults aged 18 to 50 years. Gender and vaccination may be independent potential factors that affect the changes in peripheral blood immune cells. This study collects basic clinical information from volunteers, and classifies the population based on gender and whether they have been vaccinated recently (including influenza vaccine, HPV vaccine, and SARS-CoV-2 vaccines and others), aiming at systematically classify the peripheral blood mononuclear cells of healthy adults under different conditions and search for molecular markers related to different cell types. This group is Recently vaccinated group (Male)．

Recently Vaccination

Intervention Type: BIOLOGICAL

Interventions

Recently Vaccination

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Pu

Director of Cardiovascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Pu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology, Ren Ji Hospital Shanghai, China

Locations

Cardiology, Ren Ji Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Pu, MD,PhD

Role: CONTACT

pujun310@hotmail.com

86-21-68383477

Facility Contacts

Jun Pu

Role: primary

References

Tong R, Luo L, Zhao Y, Sun M, Li R, Zhong J, Chen Y, Hu L, Li Z, Shi J, Lyu Y, Hu L, Guo X, Liu Q, Shuang T, Zhang C, Yuan A, Sun L, Zhang Z, Qian K, Chen L, Lin W, Chen AF, Wang F, Pu J. Characterizing the cellular and molecular variabilities of peripheral immune cells in healthy recipients of BBIBP-CorV inactivated SARS-CoV-2 vaccine by single-cell RNA sequencing. Emerg Microbes Infect. 2023 Dec;12(1):e2187245. doi: 10.1080/22221751.2023.2187245.

Reference Type: DERIVED

PMID: 36987861 (View on PubMed)

Other Identifiers

COVID-2019-VIR-SCMO study

Identifier Type: -

Identifier Source: org_study_id