COVIDNCT06763887
Evaluation of Immunogenicity of COVID-19 Vaccine in Chinese Population
An observational study of COVID, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and immune protection of COVID-19, especially the recently prevalent strains, against the background of current immunization in Chinese population Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People infected with COVID-19
Who may be able to join
- He was infected with COVID-19 from November to December 2022;
- Have not been infected with COVID-19 (the subject said that he was not infected and signed the informed consent form);
- Those who agree and sign the informed consent form.
Who cannot join
- Missing or incomplete questionnaires that affect research results;
- Individuals with combined dysfunction of important organs such as the heart, liver, and lungs;
- Mental and behavioral abnormalities;
- Intellectual disability;
- Under 18 years old or over 75 years old;
- Low understanding and communication skills.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710004
About this study
The purpose of this study is to evaluate the immunogenicity and immune protection of COVID-19, especially the recently prevalent strains, against the background of current immunization in Chinese population
- Conditions
- COVID
- Being tested
- No Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBMC
When conducting blood sample analysis, we focus on separating and evaluating in detail the composition and counting of peripheral blood mononuclear cell (PBMC). This process involves identifying and quantifying various types of mononuclear cells in the sample, such as lymphocytes, monocytes, etc. These cells are crucial for understanding an individual's immune status. Through precise separation techniques and advanced cell analysis methods, we are able to obtain accurate and detailed reports on the classification and quantity of mononuclear cells.
Measured: About two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start15 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763887
- Sponsor's protocol ID
- KY20232379-C-1
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunogenicity of COVID-19 Vaccine in Chinese Population
- ClinicalTrials.gov ID
- NCT06763887
- Acronym / sponsor ID
- KY20232379-C-1
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Jan 2025 (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.
The purpose of this study is to evaluate the immunogenicity and immune protection of COVID-19, especially the recently prevalent strains, against the background of current immunization in Chinese population
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: No Interventions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People infected with COVID-19
Key inclusion criteria (3 listed)
- He was infected with COVID-19 from November to December 2022;
- Have not been infected with COVID-19 (the subject said that he was not infected and signed the informed consent form);
- Those who agree and sign the informed consent form.
Key exclusion criteria (6 listed)
- Missing or incomplete questionnaires that affect research results;
- Individuals with combined dysfunction of important organs such as the heart, liver, and lungs;
- Mental and behavioral abnormalities;
- Intellectual disability;
- Under 18 years old or over 75 years old;
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 |
|---|---|---|
| No InterventionsNo intervention | Other | Observation |
Primary outcome
PBMC
Time frame: About two and a half years
When conducting blood sample analysis, we focus on separating and evaluating in detail the composition and counting of peripheral blood mononuclear cell (PBMC). This process involves identifying and quantifying various types of mononuclear cells in the sample, such as lymphocytes, monocytes, etc. These cells are crucial for understanding an individual's immune status. Through precise separation techniques and advanced cell analysis methods, we are able to obtain accurate and detailed reports on the classification and quantity of mononuclear cells.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID, run by Xijing 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PBMC (time frame: About two and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.