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

NCT04871932 | Recruiting DMC

• 1 other identifier: COVID-2019-VIR-SCMO study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System and Related Disorders

Keywords

Cohort study; Immune System; PBMC; China

Outcome Measures

Primary Outcomes (1)

• Changes in classification of human peripheral blood mononuclear cells

  The primary endpoint will be the changes in classification of human peripheral blood mononuclear cells at single cell resolution.

  up to five years

Study Arms (4)

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)．

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)．

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)．

Biological: Recently Vaccination

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)．

Biological: Recently Vaccination

Interventions

Recently Vaccination BIOLOGICAL

Recently vaccinated group (Female); Recently vaccinated group (Male)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults with Han nationality

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Cardiology, Ren Ji Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36987861 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood samples from each donor were obtained to get the peripheral blood mononuclear cells (PBMCs)

Study Officials

• Jun Pu, MD,PhD

  Cardiology, Ren Ji Hospital Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Medicine

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 4, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): November 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)