Immune System and Related DisordersNCT04871932
COVID-2019 Vaccine Immune Response Base on Single Cell Multi-Omics
An observational study of Immune System and Related Disorders, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System and Related Disorders
- What is being tested?
- Recently Vaccination
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 3 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults with Han nationality
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- Recently Vaccination
- Keywords
- Cohort study, Immune System, PBMC, China
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recently VaccinationBiological
| Study group | Role | What they receive |
|---|---|---|
| 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)． Receives: 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)． Receives: Biological: Recently Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Feb 2021
- Primary completion3 Nov 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune System and Related DisordersStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Pu, RenJi Hospital
- Investigators
- Jun Pu, MD,PhD, Principal investigator, Cardiology, Ren Ji Hospital Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871932
- Sponsor's protocol ID
- COVID-2019-VIR-SCMO study
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36987861
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04871932
- Acronym / sponsor ID
- COVID-2019-VIR-SCMO study
- Conditions
- Immune System and Related Disorders
- Keywords
- Cohort study, Immune System, PBMC, China
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Biological: Recently VaccinationThis 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 vaccinated group (Male) | – | Biological: Recently VaccinationThis 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)． |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults with Han nationality
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recently Vaccination | Biological | Recently vaccinated group (Female), Recently vaccinated group (Male) |
Primary outcome
Changes in classification of human peripheral blood mononuclear cells
Time frame: up to five years
The primary endpoint will be the changes in classification of human peripheral blood mononuclear cells at single cell resolution.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 36987861Tong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu, MD,PhD principal investigator
Cardiology, Ren Ji Hospital Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune System and Related Disorders, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD,PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in classification of human peripheral blood mononuclear cells (time frame: up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.